0227 Broadcast DATE: June 17, 2010 SUBJECT: RTOG 0227, Action Letter & Study Closure at 5PM EST Today Action Letter and Study Closure RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma" RTOG has received an ACTION LETTER from NCI/NIH for rituximab (NSC 687451, IND 7028). Accrual of new patients to RTOG 0227 is SUSPENDED per NCI guidelines. Because permanent closure to this study was planned for June 25, as broadcast on June 11, the study will instead permanently close to accrual as of 5pm EST, Thursday, June 17, 2010. Patients currently on study may continue on study provided they are informed of the new risks identified as part of the CAEPR update in the Action Letter. Per CTEP's policy for trials with a CTEP status of "Closed to Accrual," RTOG will not issue an amendment to this protocol for site IRB approval. However, all sites should follow local IRB or Operations Office procedures and requirements. Please notify your affiliates that are not on e-mail. - Action Letter_Rituximab_NSC 687451_IND 7028_June 16, 2010.pdf DATE: June 11, 2010 SUBJECT: RTOG 0227, Closure Notice Closure Notice RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma," will close to patient accrual at 5 PM EST, Friday, June 25, because the study has met its accrual objective. Please notify your affiliates that are not on e-mail. DATE: April 6, 2010 SUBJECT: RTOG 0227, Amended Amended RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma," Amendment 7: As mandated by CTEP, CTC v. 2.0 was replaced with CTEP's Active Version CTCAE (v. 4.0). NOTE: Institutions will continue to submit patient data via the appropriate study case report forms. For adverse event reporting via AdEERS, sites will utilize CTEP's Active Version CTCAE (v. 4.0). Section 3.1.6 and Eligibility Checklist: Age ? 18 was added because it was inadvertently omitted. Appendix I/Sample Consent: "Annually for five years was corrected to annually." Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0227/summary_changes.html You may download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0227/0227.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. If the amendment involves changes to the risks section of the consent, RTOG recommends re-consenting patients on this trial; however, your local IRB will have the final authority. Sites must submit IRB approval for the amendment to CTSU. DATE: September 25, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP018230FU9.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at <<http://www.rtog.org>> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: July 18, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513,(0525) & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE ******Please note: The safety report cover page states it is an initial submission when indeed it is a follow-up. The Medwatch reflects the accurate information*** RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP018230 FU8.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: July 11, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513,(0525) & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE ***Please note: The safety report cover page states it is an initial submission when indeed it is a follow-up. The Medwatch reflects the accurate information*** RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2008SP010385 FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 13, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513,(0525) & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2008SP009832 Initial.pdf - 2008SP010385 Initial.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 9, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE ****Please Note**** Safety Report 2008SP009302 is a re-broadcast. There is newly added information to the attached report. This report replaces the Safety Report broadcast initially on 5/29/2008. RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2008SP009306 FU1.pdf - 2008SP009302 Initial Update.pdf - 2008SP003086 FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 29, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP018230 FU7.pdf - 2007SP007552FU9.pdf - 2008SP009306.pdf - 2008SP009302.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 16, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2008SP001606 F-U 2.pdf - 2008SP001606 F-U 1.pdf - 2007SP018230 FU6.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 2, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2008SP006508 FU1.pdf - 2008SP006508 initial.pdf - 2008SP000756 F-U2.pdf - 2008SP001606 initial.pdf - 2008SP001728 FU2.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 1, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE During a recent audit of broadcast RTOG Safety Reports, it was discovered that the following Safety Reports for Temozolomide, which were previously broadcast on 2/7/07 and 3/15/07, may not have been received by all participating sites. Please disregard any duplicate reports. RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 22Jan2007_2006SP008904_analysis.doc - 22Jan2007_2006SP008904_Medwatch.pdf - 23Jan2007_2006SP004547_analysisfu1.doc - 23Jan2007_2006SP004547_MedWatch_FU1.pdf - 24Jan2007_2007SP001239_analysis.doc - 24Jan2007_2007SP001239_Medwatch.pdf - 26Jan2007_2007SP000310_analysis.doc - 26Jan2007_2007SP000310_Medwatch.pdf - 26Jan2007_2006SP008904_analysisfu2.doc - 26Jan2007_2006SP008904_MedWatch_FU2.pdf - 31Jan2007_2006SP004547_analysisfu2.doc - 31Jan2007_2006SP004547_MedWatch_FU2.pdf - 12Mar2007_2007SP003140_analysisfu2.doc - 12Mar2007_2007SP003140_MedWatch_FU2.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 11, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2008SP000756 F-U1.pdf - 2007SP018230 FU5.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 28, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP007552 FU8.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: February 29, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2008SP03086 initial.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: February 28, 2008 SUBJECT: RTOG 0227, Amended Amended RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma," Amendment # 6. The contact information for Dr. Glass was revised. Please see the complete summary of changes at http://www.rtog.org/members/protocols/0227/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0227/0227.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info," or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: February 15, 2008 SUBJECT: RTOG RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP018230 FU4.pdf - 2008SP001728 FU 1.pdf - 2008SP002006 FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: February 8, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP018230 FU3.pdf - 2006041447 FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: January, 4, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP023974 FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: December 18, 2007 SUBJECT: RTOG Holiday Drug Shipment Hours The deadline to order drug for the holidays is approaching fast. Please be aware of your institution's supply of pharmaceutical supplied drugs during the holiday shipment hiatus and reorder now or plan accordingly. BMS [(0324), (0234) & 0522] the distributor of Cetuximab/Erbitux reminds us: The holiday season is quickly approaching. We remind you that BMS drug distribution center will be closed for Cetuximab shipments as follows: Warehouse Closure Date Last Shipment Date Monday, December 24th through Wednesday, January 2nd, 2008 Wednesday, December 19th BIOLOGICS [(9813), 0525 & 0521] and IV SOLUTIONS [0227, 0320, 0424, 0517 & 0518] the distributors of TEMOZOLOMIDE, TAXOTERE & ZOMETA on behalf of the supporting pharmaceutical companies for RTOG studies remind us: The holiday season is quickly approaching. The BIOLOGICS & IV SOLUTIONS drug distribution centers will be closed for all drug shipments as follows: Dates of Closure Comments Monday 12/24/07 Shipment sent on Friday 12/21/07will be delivered on Monday 12/24/07. Tuesday 12/25/07 Monday 12/31/07 Shipments sent on Friday 12/28/07 will be delivered on Monday 12/31/07. Tuesday 01/01/08 DATE: December 13, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP020357 FU3.pdf - 2007SP018230 FU2.pdf - 2007SP012156 FU3.pdf - 2007sp023870 initial.pdf - 2007SP023974 initial.pdf - 2007SP012156 FU4.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments DATE: November 27, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2006062337 FU2.pdf - 2007SP014751 FU4.pdf - 2007SP020934 FU1.pdf - 2007SP020357 FU2.pdf - 2007SP007552 FU7.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments DATE: November 14, 2007 SUBJECT: RTOG (9813), 0227, 0320, 0424. & 0525 PROTOCOL NOTICE: TEMOZOLOMIDE Holiday Drug Shipment Hours BIOLOGICS [(9813) & 0525] and IV SOLUTIONS [0227, 0320 & 0424] the distributors of TEMOZOLOMIDE on behalf of Schering-Plough for RTOG studies remind us: The holiday season is quickly approaching. The BIOLOGICS & IV SOLUTIONS drug distribution centers will be closed for Temozolomide shipments as follows: Dates of Closure Comments Thursday 11/22/07 Shipments sent on Wednesday 11/21/07 will not be delivered until Friday 11/23/07. Friday 11/23/07 Monday 12/24/07 Shipment sent on Friday 12/21/07 will be delivered on Monday 12/24/07. Tuesday 12/25/07 Monday 12/31/07 Shipments sent on Friday 12/28/07 will be delivered on Monday 12/31/07. Tuesday 01/01/08 BIOLOGICS distributes Temozolomide for the Following RTOG studies: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" IV SOLUTIONS distributes Temozolomide for the Following RTOG studies: RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" HAPPY HOLIDAYS! DATE: November 7, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) “A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA” (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) “A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME” RTOG 0424 “A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMENFOR HIGH RISK LOW-GRADE GLIOMAS” RTOG 0513 “A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME” RTOG 0525 “PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA” RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP020357 FU1.pdf - 2007SP020934 (15 day) initial.pdf - 2007SP007552 FU6.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments DATE: October 26, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP012156 F-U 2.pdf - 2007SP018230 FU1.pdf - 2007SP020357 Initial.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: October 5, 2007 SUBJECT:RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE,RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP014751 FU3.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at http://www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: September 18, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE -BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP014751 F-U2.pdf - 2007SP007552 FU4.pdf - 2007SP007552 FU 5.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: August 29, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) “A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA” (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) “A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME” RTOG 0424 “A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS” RTOG 0513 “A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME” RTOG 0525 “PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA” The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007sp007552 FU 3.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: August 7, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMENFOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP014751 15 day Initial 15 day FU 1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: July 27, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP14808 7 day initial.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: July 20, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE,RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS RINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP012156 (7 day ) Initial 2007SP012478 (15 day ) Initial.pdf - 2007SP006588 (15 day) F-U 1 2007SP012478 (15 day) Initial.pdf - 2007SP007552 (15 day) F-U 1.pdf - 2007SP012156 (15 day) Initial.pdf - 2007SP006588 (15 day ) F-U 2.pdf - 2007SP012478 (15 day ) F-U 1.pdf - 2007SP006588 (15 day) F-U 1 2007SP007552 (15 day) F-U 1 2007SP012478 (15 day) F-U 1.pdf - 2007SP006588 (15 day) F-U 2 2007SP012156 (15 day) F-U 1.pdf - 2007SP012156 (15 Day) F-U 1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 7, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 04Jun2007_2007SP003140_analysis.doc - 04Jun2007_2007SP003140_Medwatch.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 5, 2007 SUBJECT: RTOG 0227, Amended Amended RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma," Amendment 5: Neuroimaging was revised to include head CT scans if MRIs are not feasible; several pre-treatment assessments were revised from one week to four weeks prior to the first treatment cycle. Please see the complete summary of changes at http://www.rtog.org/members/protocols/0227/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0227/0227.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Web registration is available 24/7. Information and instructions available at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 5, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 31May2007_2007SP007552_analysis.doc - 31May2007_2007SP007552_Medwatch.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 1, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 30May2007_1998-12-0033_analysis.doc - 30May2007_1998-12-0033_Medwatch.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 31, 2007 SUBJECT: Web-Based Data Collection RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 24May2007_2007SP006582_analysis.doc - 24May2007_2007SP006582_MedWatch.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 25, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 09May2007_2007SP000438_analysis.doc - 09May2007_2007SP000438_MedWatch.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 11, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 30Apr2007_2007SP006588_analysis.doc - 30Apr2007_2007SP006588_MedWatch.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 23, 2007 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do no require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 13Apr2007_2007SP006582_analysis (3).doc - 13Apr2007_2007SP006582_Medwatch.pdf - 17Apr2007_2006SP004547_analysis (3).doc - 17Apr2007_2006SP004547_Medwatch.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 11, 2007 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXA, TERITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do no require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html - 30Mar2007_2007SP003140_analysisfu5.doc - 30Mar2007_2007SP003140_MedWatch_FU5.pdf - 27Feb2007_2007SP003140_analysisfu1.doc - 27Feb2007_2007SP003140_MedWatch_FU1.pdf - 22Feb2007_2007SP003140_analysis.doc - 22Feb2007_2007SP003140_MedWatch.pdf Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 27, 2007 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 “A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA” (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) “A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME” RTOG 0424 “A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS” RTOG 0513 “A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME” RTOG 0525 “PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA” The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do no require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html - 15Mar2007_2007SP003140_analysis.doc - 15Mar2007_2007SP003140_MedWatch.pdf - 19Mar2007_2007SP003140_analysis.doc - 19Mar2007_2007SP003140_Medwatch.pdf Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 15, 2007 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 12Mar2007_2007SP003140_analysisfu2.doc - 12Mar2007_2007SP003140_MedWatch_FU2.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: February 27, 2007 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do no require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 15Feb2007_2006SP004547_analysis.doc - 15Feb2007_2006SP004547_Medwatch.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: February 16, 2007 SUBJECT: RTOG 0227- PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR RITUXIMAB RTOG has received safety report(s) from NCI for RITUXIMAB The Following RTOG studies involve RITUXIMAB: RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" Although the safety report(s) included here do no require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Rituximab-Investigator Notification-2-5-2007.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: February 7, 2007 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 22Jan2007_2006SP008904_analysis.doc - 22Jan2007_2006SP008904_Medwatch.pdf - 26Jan2007_2006SP008904_analysisfu2.doc - 26Jan2007_2006SP008904_MedWatch_FU2.pdf - 23Jan2007_2006SP004547_analysisfu1.doc - 23Jan2007_2006SP004547_MedWatch_FU1.pdf - 31Jan2007_2006SP004547_analysisfu2.doc - 31Jan2007_2006SP004547_MedWatch_FU2.pdf - 26Jan2007_2007SP000310_analysis.doc - 26Jan2007_2007SP000310_Medwatch.pdf - 24Jan2007_2007SP001239_analysis.doc - 24Jan2007_2007SP001239_Medwatch.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: January 24, 2007 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 17Jan2007_2007SP000438_analysis.doc - 17Jan2007_2007SP000438_Medwatch.pdf - 18Jan2007_2007SP000438_analysis.doc - 18Jan2007_2007SP000438_Medwatch.pdf - 18Jan2007_2006SP008904_analysis.doc - 18Jan2007_2006SP008904_Medwatch.pdf Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: January 12, 2007 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 “A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA” (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) “A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME” RTOG 0424 “A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMENFOR HIGH RISK LOW-GRADE GLIOMAS” RTOG 0513 “A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME” RTOG 0525 “PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA” The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. Please notify your affiliates that are not on e-mail. - 02Jan2007_2006-07-1249_analysis.doc - 02Jan2007_2006-07-1249_Medwatch.pdf - 05Jan2007_2006SP008904_analysis.doc - 05Jan2007_2006SP008904_Medwatch.pdf If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.orgby selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: December 14, 2006 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. Please notify your affiliates that are not on e-mail. - 11Dec2006_2006-04-1447_Medwatch.pdf - 11Dec2006_2006-04-1447_analysis.doc If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: December 11, 2006 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. - 30Nov2006_2006SP004547_analysis.doc - 30Nov2006_2006SP004547_Medwatch.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: November 17, 2006 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 “A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA” (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) “A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME” RTOG 0424 “A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS” RTOG 0513 “A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME” RTOG 0525 “PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA” The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. Please notify your affiliates that are not on e-mail. - 07Nov2006_2006SP004704_analysis 2.doc - 07Nov2006_2006SP004704_Medwatch FU 1.pdf - 07Nov2006_2006SP002722_analysis 2 FU1.doc - 07Nov2006_2006SP002722_Medwatch FU 1.pdf - 13Nov2006_2006SP002722_analysis 2 FU2.doc - 13Nov2006_2006SP002722_Medwatch FU 2.pdf To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments.If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Thomas Wudarski at twudarski@acr-arrs.org. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: November 03, 2006 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 “A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA” (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) “A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME” RTOG 0424 “A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS” RTOG 0513 “A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME” RTOG 0525 “PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA” The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. The safety report(s) do not require revisions to the above protocol at this time. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. - 2005-11-1372 Corrected Follow-Up 3 analysis page (2) [doc] - 23Oct2006_2005-11-1372_Medwatch [pdf] - 27Oct2006_2006SP002722_analysis [doc] - 27Oct2006_2006SP002722_MedWatch [pdf] - 01Nov2006_2006SP004704_analysis_corrected version [doc] - 01Nov2006_2006SP004704_MedWatch [pdf] If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org. b>Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: October 24, 2006 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424. 0513 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 “A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA” (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) “A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME” RTOG 0424 “A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS” RTOG 0513 “A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME” RTOG 0525 “PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA” The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - Oct112006_2006-07-1249_Medwatch [pdf] - 11Oct2006_2006-07-1249_analysis [doc] - 12Oct2006_2006-08-0388_analysis fu2 [doc] - Oct122006_2006-08-0388_MedWatch fu2 [pdf] - 19Oct2006_2006-06-2337_analysisfu1 [doc] - 19Oct2006_2006-06-2337_MedWatch_FU1 [pdf] - 18Oct2006_2005-11-1372_analysis fu2 [doc] - 18Oct2006_2005-11-1372_analysis fu#2 [pdf] Please notify your affiliates that are not on e-mail. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: October 5, 2006 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2006-07-1249 _IND MEDWATCH FU 2 [pdf] - Analysis page 2006-07-1249 FU 2 [doc] - 2006SP000744_IND_MEDWATCH FU2 [pdf] - Analysis page 2006SP000744 FU2 2 [doc] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: October 3, 2006 SUBJECT: IMPORTANT NEW RTOG DRUG ACCOUNTABILITY PROCEDURE RTOG will now require study-specific drug accountability recording forms (DARFs) for pharmaceutical-supplied studies. Study specific DARFs will be posted on the RTOG web site with the study forms, as well as in the initial broadcast for each protocol requiring drug review. Starting January 2007 these forms will be reviewed as part of the RTOG audit, but will not be part of the final CTMB audit score. No deficiencies will be cited for any documentation inaccuracies prior to January 2007. A count of these pharmaceutical-supplied drugs will be required at the audit, hence a pharmacy visit will need to be scheduled as part of the audit. We are starting this new initiative with the studies utilizing temozolomide. Please note the following: RTOG utilizes temozolomide in several studies with a variety of distribution mechanisms. It is important to read each protocol carefully in order to obtain drug from the appropriate distributor in time for dispensing the drug to patients correctly. Drug supplies can not be shared across studies as formulations may differ slightly. The following table will illustrate the study differences: 9813 Biologics By patient 0525 Biologics By patient 0227 IVS Starter pack* 0320 IVS Starter pack* 0424 IVS Starter pack* *Each patient is sent a starter pack with capsules of various strengths appropriate for their first dose cycle. For subsequent cycles, sites may mix and match from their supply on hand in order to give patients the best combination of capsules for their prescribed dose. Patients on studies meant to receive drug free of charge must not receive commercial drug and be charged for it. All other brain tumor studies with temozolomide as part of the treatment plan use commercially available product and the patient's insurance should be billed for the cost. Please watch for other pharmaceutical supplied study related broadcasts in the near future- thank you! - Investigational Agent Accountability Record (6-2006) [doc] - 0525 Investigational Agent Accountability Record (6-2006) [doc] - 0227 Investigational Agent Accountability Record (6-2006) [doc] - RTOG 0320 0424 Investigational Agent Accountability Record (6-2006) [doc] - RTOG 0320 Investigational Agent Accountability Record (6-2006) [doc] DATE: September 28, 2006 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2006-07-1249_IND 44162 FU 1 [pdf] - 2006-07-1249_IND_ANALYSIS PAGE (2) FU 1 [doc] - 2006SP000744_IND_44162 FU 1 [pdf] - 2006SP000744_IND 44162 ANALYSIS PAGE (2) FU 1 [doc] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: September 27, 2006 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2006-07-1249_IND 44162 FU 1 [pdf] - 2006-07-1249_IND_ANALYSIS PAGE (2) FU 1 [doc] - 2006SP000744_IND_44162 FU 1 [pdf] - 2006SP000744_IND 44162 ANALYSIS PAGE (2) FU 1 [doc] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: September 22, 2006 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2006-08-0388_IND_ANALYSIS PAGE (2) Follow-up 1 [doc] - 2006-08-0388_IND_Temozolomide Follow-up 1 [pdf] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: September 19, 2006 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2006SP000744_IND initial [pdf] - Analysis 2006SP000744 (2) [doc] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: August 30, 2006 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. The safety report(s) do not require revisions to the above protocol at this time. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html - 2006-08-0388 15 Day IND Alert Cover Memo [doc] - 2006-08-0388 ANALYSIS [pdf] - 2006-08-0388 MEDWATCH [pdf] - 2006-03-1739 (Correction) 15-Day IND Alert Cover Memo (2) ,follow-up (3) [doc] - 2006-03-1739 analysis follow-up (3) [pdf] - 2006-03-1739 medwatch Follow-up(3).pdf [pdf] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: August 9, 2006 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2006-07-0712 (follow-up) 15-Day IND Alert Cover Memo (2) [doc] - 2006-07-0712 ANALYSIS [pdf] - 2006-07-0712 MEDWATCH [pdf] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: August 4, 2006 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2006-07-0712 15-Day IND Alert Cover Memo [doc] - 2006-07-0712 ANALYSIS [pdf] - 2006-07-0712 MEDWATCH.pdf [pdf] - 2006-07-1249 (7 day) [doc] - 2006-07-1249 MEDWATCH 7 Day [pdf] - 2006-07-1249 (15 day) [doc] - 2006-07-1249_ANALYSIS 15 day [pdf] - 2006-07-1249_MEDWATCH 15 day [pdf] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: July 20, 2006 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2006-06-2337 15-Day IND Alert Cover Memo 2 initial [DOC] - 2006-06-2337 ANALYSIS [PDF] - 2006-06-2337 MEDWATCH.pdf [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 13, 2006 SUBJECT: RTOG 0227, Amended Amended RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma," Amendment # 4. Changes were made to reflect: (1) the establishment of a temozolomide MTD of 100 mg/m2, (2) current AE reporting guidelines, (3) contact information for LDS Hospital, and (4) the timeline for CSF evaluations. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0227/summary_changes.html You may download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0227/0227.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 15, 2006 SUBJECT: RTOG (9813), (0131), (0227), 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG (0227) "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do not require revisions to the above protocol at this time - 2006-03-1739 15 Day IND Alert Cover Memo FU - 2.doc [DOC] - 2006-03-1739 analysis FU - 2 15 day [PDF] - 2006-03-1739 MEDWATCH FU - 2 15 day [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 11, 2006 SUBJECT: RTOG (9813), (0131), (0227), 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG (0227) "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" - 2006-04-0834 15day follow up-1 [DOC] - 2006-04-0834 ANALYSIS FU-1 [PDF] - 2006-04-0834 MEDWATCH FU-1 [PDF] - 15 Day IND Alert Cover Memo doc 2006-04-0529 FU-2 [DOC] - 2006-04-0529 ANALYSIS 15 day FU-2 [PDF] - 2006-04-0529 MEDWATCH 15 day FU-2.pdf [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 5, 2006 SUBJECT: RTOG (9813), (0131), (0227), 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG (0227) "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do not require revisions to the above protocol at this time - 2006-02-1956 15 day F-U 1 [DOC] - 2006-02-1956 ANALYSIS 15 Day FU-1 [PDF] - 2006-02-1956 MEDWATCH 15 Day FU-1 [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 3, 2006 SUBJECT: RTOG (9813), (0131), (0227), 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG (0227) "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE,RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION EMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do not require revisions to the above protocol at this time - 2006-03-1739 15 Day F-U 1 [DOC] - 2006-03-1739 analysis 15 day F-U 1 [PDF] - 2006-03-1739 MEDWATCH 15 day F-U 1 [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 3, 2006 SUBJECT: RTOG (9813), (0131), (0227), 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG (0227) "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do not require revisions to the above protocol at this time - 2006-04-0529 15 Day IND Alert Cover Memo (follow-up) [DOC] - 2006-04-0529 ANALYSIS (follow-up) [PDF] - 2006-04-0529 MEDWATCH (follow-up) [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 24, 2006 SUBJECT: RTOG (9813), (0131), (0227), 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG (0227) "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do not require revisions to the above protocol at this time - 2006-04-0834 (15day) [DOC] - 2006-04-0834 analysis [PDF] - 2006-04-0834 medwatch [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 20, 2006 SUBJECT: RTOG (9813), (0131), (0227), 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG (0227) "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do not require revisions to the above protocol at this time - 2006-04-0834(7 Day) [DOC] - 2006-04-0834 MEDWATCH (7 day) [PDF] - 2006-03-1739 (15 day) [DOC] - 2006-03-1739 ANALYSIS (15 day) [PDF] - 2006-03-1739 MEDWATCH (15 day) [PDF] - 2006-03-1739 (7 day) [DOC] - 2006-03-1739 MEDWATCH (2) (7 day).pdf [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 18, 2006 SUBJECT: RTOG (9813), (0131), (0227), 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG (0227) "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do not require revisions to the above protocol at this time - 2006-02-1956 15 Day IND Alert [DOC] - 2006-02-1956 ANALYSIS [PDF] - 2006-02-1956 MEDWATCH [PDF] - 2006-04-0529 (7 day) [DOC] - 2006-04-0529 MEDWATCH [PDF] - 2006-04-0529 (15 day) [DOC] - 2006-04-0529 ANALYSIS [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 4, 2006 SUBJECT: RTOG (9813), (0131), (0227), 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: DISREGARD 3/30/06 Temozolomide Safety Report Broadcast [2006-03-1164 CIOMS] RTOG has just received notification from Schering-Plough that the Safety Report broadcast by RTOG on 3/30/06 [2006-03-1164 CIOMS] was released in error and should be withdrawn at this time. There is no need to notify your IRB of this report. We apologize for any confusion or inconvenience this may have caused. Please contact Bonita Adams of Schering-Plough with any further questions or concerns: Bonita.adams@spcorp.com Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 30, 2006 SUBJECT: RTOG (9813), (0131), (0227), 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG (0227) "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2006-03-1164-CIOMS [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 17, 2006 SUBJECT: RTOG (9813), (0131), (0227), 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG (0227) "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2005-05-1221 [DOC] - 2005-05-1221_ANALYSIS [PDF] - 2005-05-1221_MEDWATCH [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 17, 2006 SUBJECT: RTOG 0227, Updated Updated RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma," Update: Section 7.1.4-Dose and spelling of trimethoprim/sulfamethoxazole were corrected. Please see the complete summary of changes at: http://www.rtog.org/members/protocols/0227/summary_changes.html The updated protocol can be accessed on the RTOG website at: http://www.rtog.org/members/protocols/0227/0227.pdf NOTE: These updates are editorial/administrative changes to the protocols. NCI requires that these changes be documented on the protocol title page as "Update Date," not as an amendment. IRB review is not required; however, these changes must be reported to site IRBs. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG website: www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG Broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 13, 2006 SUBJECT: RTOG (9813), (0131), (0227), 0320, (0420), 0424 & 0525 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA” (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG (0227) "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 ""A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES"" RTOG (0420) “A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME” RTOG 0424 “A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS” RTOG 0525 “PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA” The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2005-05-1221 [DOC] - 2005-05-1221 analysis [PDF] - 2005-05-1221 medwatch [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: February 24, 2006 SUBJECT: RTOG 0227, Re-Opened Re-Opened to Patient Accrual RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma," has been re-opened to patient accrual. The phase II portion of this study (Arm 4) is now in effect. The maximum tolerated dose (MTD) of temozolomide from the phase I portion is 100 mg/m2. The protocol will be amended in the near future to reflect the MTD. Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site,www.rtog.org, under "Member Info" or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: February 9, 2006 SUBJECT: RTOG (9813), (0131), (0227), 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG (0227) "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 1998-09-0017 [DOC] - 1998-09-0017 analysis [PDF] - 1998-09-0017 medwatch (2) [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: January 25, 2006 SUBJECT: RTOG (9813), (0131), (0227), 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG (0227) "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 15 Day IND Alert Cover Memo 1998-09-0017 [DOC] - 1998-09-0017 analysis [PDF] - 1998-09-0017 medwatch [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: January 12, 2006 SUBJECT: RTOG 0227, Temporarily Closed Temporarily Closed Effective January 13, 5 PM ET: RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma," will be temporarily closed to patient accrual for routine toxicity evaluation. Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: December 22, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 1998-09-0017 (15day) [DOC] - 1998-09-0017 analysis [PDF] - 1998-09-0017 medwatch [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html For the latest information on the aftermath from Hurricane Katrina, please visit the ACR's dedicated web page at www.acr.org/relief. If you are a radiologist or radiation oncologist working in the affected area and seek radiologist assistance or would like to volunteer to assist those affected, please contact the ACR at (800) 227-5463 ext 4975 or 703-648-8975 or Katrina-Relief@acr.org. DATE: December 20, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 1998-09-0017 (7day) [DOC] - 1998-09-0017 medwatch [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html For the latest information on the aftermath from Hurricane Katrina, please visit the ACR's dedicated web page at www.acr.org/relief. If you are a radiologist or radiation oncologist working in the affected area and seek radiologist assistance or would like to volunteer to assist those affected, please contact the ACR at (800) 227-5463 ext 4975 or 703-648-8975 or Katrina-Relief@acr.org. DATE: December 15, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2005-11-1372 analysis [PDF] - 2005-11-1372 medwatch [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html For the latest information on the aftermath from Hurricane Katrina, please visit the ACR's dedicated web page at www.acr.org/relief. If you are a radiologist or radiation oncologist working in the affected area and seek radiologist assistance or would like to volunteer to assist those affected, please contact the ACR at (800) 227-5463 ext 4975 or 703-648-8975 or Katrina-Relief@acr.org. DATE: December 13, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2005-11-0797 (follow-up 15 day IND Alert) [DOC] - 2005-11-0797 analysis [PDF] - 2005-11-0797 medwatch [DOC] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html For the latest information on the aftermath from Hurricane Katrina, please visit the ACR's dedicated web page at www.acr.org/relief. If you are a radiologist or radiation oncologist working in the affected area and seek radiologist assistance or would like to volunteer to assist those affected, please contact the ACR at (800) 227-5463 ext 4975 or 703-648-8975 or Katrina-Relief@acr.org. DATE: December 09, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2005-11-0797 [DOC] - 2005-11-0797 analysis [PDF] - 2005-11-0797 medwatch [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html For the latest information on the aftermath from Hurricane Katrina, please visit the ACR's dedicated web page at www.acr.org/relief. If you are a radiologist or radiation oncologist working in the affected area and seek radiologist assistance or would like to volunteer to assist those affected, please contact the ACR at (800) 227-5463 ext 4975 or 703-648-8975 or Katrina-Relief@acr.org. DATE: December 07, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2005-11-1372 [DOC] - 2005-11-1372 analysis [PDF] - 2005-11-1372 medwatch [DOC] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html For the latest information on the aftermath from Hurricane Katrina, please visit the ACR's dedicated web page at www.acr.org/relief. If you are a radiologist or radiation oncologist working in the affected area and seek radiologist assistance or would like to volunteer to assist those affected, please contact the ACR at (800) 227-5463 ext 4975 or 703-648-8975 or Katrina-Relief@acr.org. DATE: November 23, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2005-11-0797 (15-day).doc [DOC] - 2005-11-0797 analysis.pdf [PDF] - 2005-11-0797 medwatch.pdf [DOC] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html For the latest information on the aftermath from Hurricane Katrina, please visit the ACR's dedicated web page at www.acr.org/relief. If you are a radiologist or radiation oncologist working in the affected area and seek radiologist assistance or would like to volunteer to assist those affected, please contact the ACR at (800) 227-5463 ext 4975 or 703-648-8975 or Katrina-Relief@acr.org DATE: November 22, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2005-11-0797 (7-day) [DOC] - 2005-11-0797 medwatch [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html For the latest information on the aftermath from Hurricane Katrina, please visit the ACR's dedicated web page at www.acr.org/relief. If you are a radiologist or radiation oncologist working in the affected area and seek radiologist assistance or would like to volunteer to assist those affected, please contact the ACR at (800) 227-5463 ext 4975 or 703-648-8975 or Katrina-Relief@acr.org. DATE: November 14, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH UPDATED SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received an updated safety report(s) from Schering-Plough for Temozolomide, eliminating the questionable causes of death noted in the previous report broadcast 11/8/05 (Schering Control Number 2005-11-0139) and also downgrading the death from possibly to unlikely related to Temozolomide. The Following RTOG studies also involve Temozolomide: RTOG 98-13 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2005-11-0139 15 day (2) [DOC] - 2005-11-0139 (15 day) medwatch (unlikely related) [PDF] - 2005-11-0139 (15 day) analysis [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html For the latest information on the aftermath from Hurricane Katrina, please visit the ACR's dedicated web page at www.acr.org/relief. If you are a radiologist or radiation oncologist working in the affected area and seek radiologist assistance or would like to volunteer to assist those affected, please contact the ACR at (800) 227-5463 ext 4975 or 703-648-8975 or Katrina-Relief@acr.org. DATE: November 10, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2005-11-0139 (7day) [DOC] - 2005-11-0139 medwatch [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <http://www.rtog.org> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html For the latest information on the aftermath from Hurricane Katrina, please visit the ACR's dedicated web page at www.acr.org/relief. If you are a radiologist or radiation oncologist working in the affected area and seek radiologist assistance or would like to volunteer to assist those affected, please contact the ACR at (800) 227-5463 ext 4975 or 703-648-8975 or Katrina-Relief@acr.org. DATE: November 03, 2005 SUBJECT: RTOG 0227 Re-Opened Re-Opened RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma," has been re-opened to patient accrual. Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info" or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: November 01, 2005 SUBJECT: RTOG 0227 Temporarily Closed Temporarily Closed RTOG 0227,"Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma," is closed to patient accrual, effective immediately, for routine toxicity evaluation. Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: October 26, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" - Temozolomide Safety Report (Followup) [DOC] - Analysis [PDF] - Medwatch [PDF] The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html DATE: October 10, 2005 SUBJECT: RTOG 0227 Health Canada Approval of Amendment 3 APPROVED BY HEALTH CANADA RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma" Regulatory Note: Prior to clinical trial commencement, there are three TPD forms that need to be completed for each site. They are as follows: Clinical Trial Site Information Form Qualified Investigator Undertaking Form Research Ethics Board Attestation Form for the current version of the protocol Each form is attached with the RTOG information included. Please complete each form and forward the packet to the RTOG Regulatory Compliance Department (fax 215-574-0300). Also, please forward your REB approval for this protocol. Should there be any REB refusals, the TPD must be notified. Once all forms have been received and reviewed at RTOG Headquarters, the Clinical Trial Site Information Form will be faxed to TPD for study commencement. If questions arise, please contact Marcella Moore at mmoore@acr-arrs.org or 215-574-3162. Please notify your affiliates who are not on this e-mail. Thank you. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html For the latest information on the aftermath from Hurricane Katrina, please visit the ACR's dedicated web page at www.acr.org/relief. If you are a radiologist or radiation oncologist working in the affected area and seek radiologist assistance or would like to volunteer to assist those affected, please contact the ACR at (800) 227-5463 ext 4975 or 703-648-8975 or Katrina-Relief@acr.org. - 0227 clinical trial site form [DOC] - 0227 No Objection Ltr [PDF] - 0227 qualified investigator undertaking [DOC] - 0227 research ethics board attestation [DOC] DATE: September 30, 2005 RTOG 9813, (0131), 0227, 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - Follow-up Alert [DOC] - Analysis [PDF] - Medwatch [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html For the latest information on the aftermath from Hurricane Katrina, please visit the ACR's dedicated web page at www.acr.org/relief. If you are a radiologist or radiation oncologist working in the affected area and seek radiologist assistance or would like to volunteer to assist those affected, please contact the ACR at (800) 227-5463 ext 4975 or 703-648-8975 or Katrina-Relief@acr.org. DATE: September 29, 2005 RTOG 9813, (0131), 0227, 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 2005-08-0258 15-day [DOC] - 2005-08-0258 analysis [PDF] - 2005-08-0258 medwatch [PDF] Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html For the latest information on the aftermath from Hurricane Katrina, please visit the ACR's dedicated web page at www.acr.org/relief. If you are a radiologist or radiation oncologist working in the affected area and seek radiologist assistance or would like to volunteer to assist those affected, please contact the ACR at (800) 227-5463 ext 4975 or 703-648-8975 or Katrina-Relief@acr.org. DATE: September 28, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, (0420) & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 “A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA” (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) “A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME” RTOG 0424 “A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS” The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - Temozolomide Safety Report [DOC] - Analysis [PDF] - Medwatch [PDF] If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org <mailto:dcorrie@acr-arrs.org> Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <http://www.rtog.org> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html For the latest information on the aftermath from Hurricane Katrina, please visit the ACR’s dedicated web page at www.acr.org/relief. If you are a radiologist or radiation oncologist working in the affected area and seek radiologist assistance or would like to volunteer to assist those affected, please contact the ACR at (800) 227-5463 ext 4975 or 703-648-8975 or Katrina-Relief@acr.org. DATE: August 30, 2005 SUBJECT: RTOG 0227 Amended Amended RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma," Amendment # 3 to exclude active hepatitis B, change the slit lamp and CSF time frames, and incorporate the revised NCI Adverse Events Reporting Guidelines. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0227/summary_changes.html You may download a copy of the protocol for IRB review by accessing the RTOG website at http://www.rtog.org/members/protocols/0227/0227.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info," or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: July 14, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, 0420 & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 “A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA” (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG 0420 “A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME” RTOG 0424 “A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS” The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - Temoyolomide Safety Report [PDF] If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org <mailto:dcorrie@acr-arrs.org> Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <http://www.rtog.org> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: July 7, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, 0420 & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 “A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA” (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG 0420 “A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME” RTOG 0424 “A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS” The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. - Temozolomide Safety Report [PDF] Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org <mailto:dcorrie@acr-arrs.org> Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <http://www.rtog.org> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 21, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, 0420 & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 “A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA” (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG 0420 “A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME” RTOG 0424 “A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS” The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 15 Day IND Alert Follow-up [DOC] - Expedited Safety Report [PDF] - Analysis [PDF] - Medwatch [PDF] If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org <mailto:dcorrie@acr-arrs.org> Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <http://www.rtog.org> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 16, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, 0420 & 0424 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 “A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA” (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG 0420 “A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME” RTOG 0424 “A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS” The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - 15 Day IND Alert [DOC] - Safety Report [PDF] - Medwatch [PDF] - Analysis [PDF] If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org <mailto:dcorrie@acr-arrs.org> Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <http://www.rtog.org> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 31, 2005 SUBJECT: RTOG 9813, (0131), 0227, 0320, 0420 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 98-13 “A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA” (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG 0420 “A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME” The safety report(s) is/are sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html The safety report(s) do/does not require revisions to the above protocols at this time. - Expedited Safety Report [PDF] - Analysis [PDF] - IND Safety Report [DOC] - Medwatch [PDF] If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org <mailto:dcorrie@acr-arrs.org> Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <http://www.rtog.org> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 4, 2005 SUBJECT: RTOG STUDY 0227: Shortage of preservative-free methotrexate At this time (and possibly for the next several months) there is an extreme shortage of preservative-free methotrexate; most of the major wholesalers in the US and Canada have none in stock. There are two manufacturers with a very limited stock that is being released on an as-need basis. Investigators who enroll patients into RTOG Study 0227 should remind their pharmacists of the shortage and suggest they call the manufacturers' customer service department to discuss purchasing a supply of methotrexate directly or via drop-shipment instead of trying to order MTX through their local wholesalers. The manufacturers are: Mayne Pharmaceuticals: 1-888-606-2245 Bedford Labs: 1-800-521-5169 DATE: April 13, 2005 SUBJECT: RTOG 0129 and 0227 Protocol Updates Updated RTOG 0129, "A Phase III Trial Of Concurrent Radiation and Chemotherapy (Followed By Surgery for Residual Primary/N2-3 Nodal Disease) for Advanced Head and Neck Carcinoma," was updated to change "nurse participant" to "nurse". Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/h0129/summary_changes.html. This updated protocol can be accessed on the RTOG website at http://www.rtog.org/members/protocols/h0129/h0129.pdf. RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma," was updated to correct CTSU's fax number on Appendix V. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0227/summary_changes.html. This updated protocol can be accessed on the RTOG website at http://www.rtog.org/members/protocols/0227/0227.pdf NOTE: These updates are editorial/administrative changes to the protocols. NCI requires that these changes be documented on the protocol title page as “Update Date”, not as a revision. IRB review is not required; however, these changes must be reported to site IRBs. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 10, 2005 SUBJECT: RTOG 9813, (0131), 0227, (0320), 0420 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide Please see Broadcast e-mail for March 10, 2005. DATE: February 1, 2005 SUBJECT: RTOG 0227: Re-opened, Amended & Updated Re-opened RTOG 0227, "A Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma." Amended and Updated RTOG 0227 has been amended (Amendment #2) and updated (Update Date: February 1, 2005). A major change to this protocol concerns the supply of temozolomide, which will now be distributed free to sites through a third party supplier. This change requires the use of a Study Agent Shipment Form (Appendix V). For those institutions who have patients already receiving commercially supplied temozolomide, the Study Agent Shipment Form must be submitted as soon as possible for patients to begin receiving free temozolomide. For a complete description of this modification as well as other changes, please see the Summary of Changes for both the amendment and update at http://www.rtog.org/members/protocols/0227/summary_changes.html NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. NOTE: The update is an editorial/administrative change to the protocol. NCI requires that this change be documented on the protocol title page as “Update Date,” not as an amendment. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. You may download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0227/0227.pdf To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: December 29, 2004 SUBJECT: RTOG 9813, (0131), (0227), (0320), 0420 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide Please see Broadcast e-mail for December 29, 2004. DATE: December 23, 2004 SUBJECT: RTOG 0227- Notice to Investigators Amendment Requirement Withdrawn (RITUXIMB) Important Updated information regarding a previous broadcast for RITUXIMAB, which requires patient notification: The recent Broadcast "Notice to Investigators-Amendment Requested for Rituximab", (copy attached) which was sent on 12/20/04 has been clarified. A determination was made by the NCI that RTOG 0227 does not require a protocol amendment because patients with Waldenstrom's macroglobulinemia and HIV infections are not part of the patient population for this study. RTOG advises; however, notifying all patients participating in this study of these findings. - Rituximab Company Letter [PDF] - Rituximab Notice Letter [DOC] An amendment to the protocol are not required at this time. Please send the report(s) to your institutional IRB. A copy also should be retained in your protocol file. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org <mailto:dcorrie@acr-arrs.org> Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <http://www.rtog.org> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: December 20, 2004 SUBJECT: RTOG 0227- Notice to Investigators-Amendment Requested for Rituximab Attached please find a notification of a labeling change to rituximab. RTOG will develop the required amendment to protocol RTOG 0227. -----Original Message----- From: Finnigan, Shanda (NIH/NCI) [mailto:finnigas@mail.nih.gov] Sent: Friday, December 17, 2004 5:35 PM To: 'abadros@umm.edu'; 'agopal@u.washington.edu'; 'ansell.stephen@mayo.edu'; 'batchelor@helix.mgh.harvard.edu'; 'bpro@mdanderson.org'; 'bsk@medicine.wisc.edu'; 'byrd-3@medctr.osu.edu'; 'damonl@medicine.ucsf.edu'; 'epnere@ohsu.edu'; Espinoza-Delgado, Igor (NIH/NIA/IRP); 'habermann.thomas@mayo.edu'; 'Hochster.howard@jimmy.harvard.edu'; 'iflinn@jhmi.edu'; 'inwards.david@mayo.edu'; 'jamesr@medicine.ucsf.edu'; 'jglassmd@neuro-oncology.org'; 'jill.lacy@yale.edu'; 'Jonathan_Friedberg@URMC.Rochester.edu'; Sparano, Joseph; 'Lin-1@medctr.osu.edu'; 'litzow.mark@mayo.edu'; 'm_smith@fccc.edu'; 'marodriguez@mdanderson.org'; 'mc1310@columbia.edu'; 'myron.czuczman@roswellpark.org'; 'press@u.washington.edu'; Stiff, Patrick; 'rabonour@iupui.edu'; 'rklasa@bccancer.bc.ca'; 'sheat@med.unc.edu'; 'skempin@salick.com'; 'smsmith@medicine.bsd.uchicago.edu'; 'steven_bernstein@urmc.rochester.edu'; 'tgriffin@cookchildrens.org'; 'tgross@chi.osu.edu'; 'tmiller@azcc.arizona.edu'; Wilson, Wyndham (NIH/NCI); 'witzig.thomas@mayo.edu'; NCI IRB Admin; 'Brenda Hunter'; Karas, Kathy; Khayat, Anita; O'Connor, Liz; Everett, Judith; Smith, Malcolm (NIH/NCI); McDonald, Jean; Harrington, Erin; Kimberly Riley; Fisher, Joy; Flickinger, Lynn M.; Walters-Page, Linda; Aiken, Ellen; 'D'Amico,Marie'; Hoffman, Wilma; Sparks, Dana Cc: Davis, Thomas (NIH/NCI) Subject: Notice to Investigators-Amendment Requested for Rituximab Importance: High Attached Please find a Notice to Investigators for Rituximab. The purpose of this letter is to alert investigators of a recent change in the labeling for Rituximab studies that will treat patients with HIV infection or Waldenstrom's macroglobulinemia. The amendment is to be submitted to PIO by close of business on January 21, 2005. This Letter may apply to the following 51 NCI Protocols: 1970 (M00-055) 2410 (01-C-0235) 2890 (01-C-0030) 312 (MC998C) 5745 (2002C0281) 5808 (ID02-148) 5818 5966 6015 (UMGCC #0307) 6057 6216 (CII0301) 6243 (12975A) 6485 (2004-0305) 6518 (OSU 0429) 6957 970 (J0004) ADVL0013 AMC-034 ANHL0121 ANHL01P1 ANHL0221 CALGB-10002 CALGB-10101 CALGB-50103 CALGB-50201 CALGB-50202 CALGB-50303 CALGB-50402 CALGB-59909 E1496 E1499 E1903 E1A02 E2499 E2903 E3402 E4402 E4494 N0087 N0189 N038H NABTT-2201 RTOG-0227 S0016 S0213 S0313 S0314 S0349 S0433 S9704 T93-0023 (93-C-0133) Please direct any questions to Thomas Davis at davisth@ctep.nci.nih.gov or phone 301-496-2522. Thank you, Shanda Finnigan, RN, BSN, CCRC Deputy Program Manager Protocol & Information Office CTEP, DCTD, NCI Contractor 301-496-1367 e-mail: pio@ctep.nci.nih.gov - Notice Rituximab Company Letter [PDF] - Notice Letter [DOC] Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: December 9, 2004 SUBJECT: RTOG 9813, 0131, 0227, 0320, 0420 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide Please see Broadcast e-mail for December 9, 2004. DATE: December 9, 2004 SUBJECT: RTOG 0227, Amended Amended RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma," Amendment #1. In response to a memo circulated by Dr. Thomas Davis regarding the development of HBV reactivation with fulminant hepatitis and hepatic failure, changes were made to Sections 4.4, 7.2.3, 7.7.4, 7.7.5, 11.1, and Appendix IA . Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0227/summary_changes.html You may download a copy of the protocol for IRB review by accessing the RTOG website at http://www.rtog.org/members/protocols/0227/0227.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: November 1, 2004 SUBJECT: RTOG 9813, 0131, 0227, 0320 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received a safety report from Schering-Plough for Temozolomide Please see Broadcast e-mail for November 1, 2004. DATE: October 28, 2004 SUBJECT: RTOG 0227 PROTOCOL NOTICE: NCI/NIH ACTION LETTER/Safety Report FOR Rituximab RTOG has received an ACTION LETTER from the NCI/NIH for Rituximab The Following RTOG studie(s) involves Rituximab: RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" This ACTION LETTER is sent automatically to the sites that have patients enrolled in the study. Please send this report to your institutional IRB. A copy also should be retained in your protocol file. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html This safety report requires action and amendments to RTOG 0227. The amended protocol will be forthcoming. - Email notice of Action Letter [DOC] - Rituximab Action Letter [PDF] If your institution plans to participate in this trial in the future, please contact Marie D'Amico, RTOG Regulatory Associate, mdamico@acr-arrs.org, 215-574-3185 for a copy of this report. Please provide your Institution number for identification and tracking purposes to receive a copy of the report. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@acr-arrs.org <mailto:dcorrie@acr-arrs.org> Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <http://www.rtog.org> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: October 15, 2004 SUBJECT: RTOG 9813, 0131, 0227, 0320 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received a safety report from Schering-Plough for Temozolomide Please see Broadcast e-mail for October 15, 2004.