0627 Broadcast DATE: August 10, 2010 SUBJECT: RTOG 0627, Closure of Stage 1B Cohort To Occur today, Tuesday 8/10 Closure of Stage 1B Cohort The stage 1B cohort of RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme," will close to patient accrual at 5 PM EST today Tuesday, August 10, because it has accrued the required number of patients. (Notice of this closure was broadcast on July 27, 2010.) Accrual to this protocol will be suspended while data from the stage 1B cohort are analyzed to determine whether there is sufficient evidence of response to proceed to the next stage of accrual. A broadcast will be sent when this decision has been made. Please notify your affiliates that are not on e-mail. 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. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: August 9, 2010 SUBJECT: RTOG 0627 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR DASATINIB RTOG has received a safety report from NCI for DASATINIB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve DASATINIB: RTOG 0627: PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME Although the safety report included here does 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. 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 <<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 - BMS-354825, AE -1983486, Protocol AALL0622,-FU1.pdf DATE: July 27, 2010 SUBJECT: RTOG 0627, Closure of Stage 1B Cohort To Occur Tuesday 8/10 Closure of Stage 1B Cohort The stage 1B cohort of RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme," will close to patient accrual at 5 PM EST on Tuesday, August 10, because it has accrued the required number of patients. Accrual to this protocol will be suspended while data from the stage 1B cohort are analyzed to determine whether there is sufficient evidence of response to proceed to the next stage of accrual. A broadcast will be sent when this decision has been made. Please notify your affiliates that are not on e-mail. 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. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: July 22, 2010 SUBJECT: RTOG 0627, Amended & Updated Amended and Updated RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme" Amendment 8 Starting October 1, 2010, AdEERS for RTOG 0627 must be reported using CTCAE version 4.0. Related changes were made to Section 7.7. All AE reporting on the study case report forms and dose modification decisions will continue to use CTCAE version 3.0. Update The Fed Ex account number was updated in Appendix V. Sites can access the summaries of changes for the amendment and update at http://www.rtog.org/members/protocols/0627/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site http://www.rtog.org/members/protocols/0627/0627.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 of the amendment is provided in parentheses. The "Update Date" indicates that editorial/administrative changes were made to the protocol after NCI approved the amendment. NCI requires that these changes be documented on the protocol title page as an update, not as an amendment. 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. IRB review of an update is not required; however, these changes must be reported to site IRBs. DATE: July 7, 2010 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. 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. - Dasatinib (BMS-354825), AE 1983486, Protocol AALL0622, -ISR.PDF DATE: June 25, 2010 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. 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 - Dasatinib (BMS-354825), AE 1640686, Protocol RTOG-0627, -FU1.pdf Please notify your affiliates that are not on e-mail. DATE: June 25, 2010 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. 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 - Dasatinib (BMS-354825), AE 1640686, Protocol RTOG-0627, -FU1.pdf Please notify your affiliates that are not on e-mail. DATE: May 11, 2010 SUBJECT: RTOG 0627, Amended Amended RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme," Amendment 7: In response to a request for an amendment (RA) from CTEP, the protocol was amended to reflect the migration of the Comprehensive Adverse Events and Potential Risks List (CAEPR) for dasatinib from Common Terminology Criteria for Adverse Events (CTCAE) 3.0 language to CTCAE 4.0 language. Please Note: Although the revised CAEPR reflects the CTCAE migration, there is no new or modified risk information for dasatinib. Sites can access the summaries of changes for the amendment at http://www.rtog.org/members/protocols/0627/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site http://www.rtog.org/members/protocols/0627/0627.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 of the amendment 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. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. DATE: April 5, 2010 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. 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. - Dasatinib (BMS-3544825), AE-1640686, Protocol RTOG-0627, -ISR.PDF DATE: December 17, 2009 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. - Dasatinib (BMS-354825), AE-1263182, Protocol S0325, -FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at https://silver1.phila.acr.org/Clinical_RTOG/pgindex.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 <<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: October 2, 2009 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. - Bevacizumab CCI-779, AE-1710309, Protocol E2804, -ISR.PDF Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail mbuado@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: August 6, 2009 SUBJECT: RTOG 0627 Form Revision RTOG Study #0627 Study Title: Phase II trial of dasatinib in patients with recurrent glioblastoma multiforme Form Revision The Central Pathology Form (P4) for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/members/forms/0627/main.html The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date P4    P4     08/05/09   Changes Made: Address for the shipment of tissue has been changed to Dr Ken Aldape's department. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after 8/20/09 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. RTOG Data Management DATE: August 4, 2009 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. - Dasatinib, AE-1263182, Protocol S0325, -ISR.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 2, 2009 SUBJECT: Follow-Up: RTOG 0627, Notification of Action Letter and Amendment Forthcoming (Re-Opened & Amended) RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme," has been re-opened to accrual and amended as follows: Action Letter (Amendment 4): RTOG has received an Action Letter from NCI/NIH for dasatinib (BMS-354825, NSC 732517, IND 73969). Accrual of new patients WILL REMAIN SUSPENDED until the IRB of record has reviewed and approved the CTEP-approved amendment for this study that addresses the information in the Action Letter. The Action Letter is attached and must accompany the amendment. Amendment 5: Based on a protocol-specified efficacy analysis, the protocol was amended to allow intrapatient dose escalation. Pharmacokinetic analyses were also incorporated. Amendment 6: Clarifications were made to the AE reporting and statistical sections. Sites can access complete Summary of Changes for Amendment 4, Amendment 5, and Amendment 6 at http://www.rtog.org/members/protocols/0627/summary_changes.html Sites can download a copy of the amended protocol for IRB review at http://www.rtog.org/members/protocols/0627/0627.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date that the most recent amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Please submit the amendments and Action Letter to your institutional IRB. A copy should be retained in your protocol file. CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Because these amendments involve 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. Note: RTOG has expired all prior site IRB approvals for the study. U.S. sites and Canadian sites must fax a copy of the IRB/REB approval letter to the CTSU Regulatory Office (215-569-0206) prior to registering patients. Please notify your affiliates that are not on e-mail. 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. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at http://www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. - ACTION LETTER_Dasatinib (BMS-354825)_NSC 732517_IND 73969_February 10, 2009.pdf _____________________________________ From: RTOGBroadcast Sent: Tuesday, February 24, 2009 2:54 PM To: RTOGBroadcast Cc: RTOGBroadcast Subject: RTOG 0627, Notification of Action Letter and Amendment Forthcoming Importance: High RTOG has received an ACTION LETTER from NCI/NIH for dasatinib (BMS-354825, NSC 732517, IND 73969). The Action Letter pertains to RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme" (temporarily closed to accrual). Patients currently on study may continue on study provided they are informed of the new and/or modified risk information. This information should be communicated to patients already enrolled on study without waiting for IRB review/approval since this information represents a significant new finding(s) that developed during the course of the research that may relate to a patient's willingness to continue participation and per the Office for Human Research Protections, the regulations do not require IRB review and approval of statements describing such significant new findings before they are provided to already enrolled patients. Documentation of their informed consent should be carried out according to local IRB requirements. Please see the attached risk modifications, extracted from the action letter. RTOG will broadcast the action letter and amended protocol in the near future. Please be advised, in addition to the action letter amendment, RTOG will incorporate additional modifications to the protocol, at which time the study is expected to re-open to patient accrual. Please notify your affiliates that are not on e-mail. 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. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 27, 2009 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. - dasatinib-ib08-esr02-fu01.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 16, 2009 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. - dasatinib-ib08-esr02.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 6, 2009 SUBJECT: RTOG Investigator Brochure Update Notification of an updated Investigator Brochure has recently been received by RTOG for the following studies: RTOG 0619"A RANDOMIZED PHASE II TRIAL OF CHEMORADIOTHERAPY VERSUS CHEMORADIOTHERAPY AND VANDETANIB FOR HIGH-RISK POSTOPERATIVE ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" The IB for the Vandetanib used in this study is available on the RTOG Website at http://www.rtog.org/investbrochure.html . The Summary of Changes (SOC) is included as part of the IB Investigator Brochures for other applicable RTOG Studies remain available from the following sources: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) The IB & Summary of Changes (SOC) for the Temozolomide used in this study is available on the RTOG Website at http://www.rtog.org/investbrochure.html . Please refer to the Protocol Notification broadcast sent 2/3/09 for applicable password information. RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING THREE-DIMENSIONAL CONFORMAL RADIOTHERAPY (3D-CRT) or INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" The IB for the Bevacizumab used in these studies can be obtained from the NCI/PMB by contacting the IB Coordinator at ibcoordinator@mail.nih.gov or (301) 496-5725. RTOG 0524 "A PHASE I/II TRIAL OF A COMBINATION OF PACLITAXEL AND TRASTUZUMAB WITH DAILY IRRADIATION OR PACLITAXEL ALONE WITH DAILY IRRADIATION FOLLOWING TRANSURETHRAL SURGERY FOR NON-CYSTECTOMY CANDIDATES WITH MUSCLE-INVASIVE BLADDER CANCER" The IB for the Trastuzumab used in this study can be obtained from the NCI/PMB by contacting the IB Coordinator at ibcoordinator@mail.nih.gov or (301) 496-5725. RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" The IB for the Dasatinib used in this study can be obtained from the NCI/PMB by contacting the IB Coordinator at ibcoordinator@mail.nih.gov or (301) 496-5725. DATE: February 24, 2009 SUBJECT: RTOG 0627, Notification of Action Letter and Amendment Forthcoming RTOG has received an ACTION LETTER from NCI/NIH for dasatinib (BMS-354825, NSC 732517, IND 73969). The Action Letter pertains to RTOG 0627, ”Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme” (temporarily closed to accrual). Patients currently on study may continue on study provided they are informed of the new and/or modified risk information. This information should be communicated to patients already enrolled on study without waiting for IRB review/approval since this information represents a significant new finding(s) that developed during the course of the research that may relate to a patient’s willingness to continue participation and per the Office for Human Research Protections, the regulations do not require IRB review and approval of statements describing such significant new findings before they are provided to already enrolled patients. Documentation of their informed consent should be carried out according to local IRB requirements. Please see the attached risk modifications, extracted from the action letter. - Dasatinib Risk Modification Summary.doc RTOG will broadcast the action letter and amended protocol in the near future. Please be advised, in addition to the action letter amendment, RTOG will incorporate additional modifications to the protocol, at which time the study is expected to re-open to patient accrual. Please notify your affiliates that are not on e-mail. 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. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: February 3, 2009 SUBJECT: Investigator Brochure Update Alert Notification of updated Investigator Brochures has recently been received by RTOG for the following 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) The IB & Summary of Changes for the Temozolomide used in this study is available on the RTOG Website at http://www.rtog.org/investbrochure.html. Please refer to the Protocol Notification broadcast sent 2/3/09 for applicable password information RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" The IB for the Dasatinib used in this study can be obtained from the NCI/PMB by contacting the IB Coordinator at ibcoordinator@mail.nih.gov or (301) 496-5725 DATE: January 9, 2009 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. - dasatinib-ib08-esr01.pdf - dasatinib-ib08-esr01-fu01.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 <<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: October 30, 2008 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB *** Please note there is an error on the CARES Form that lists the attached Safety report as a Expedited Safety Report #3. It has been confirmed with BMS that this is an Initial Report. Please make a note of this. Thanks. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. - dasatinib-ib07-esr03_oct27_930031647.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: May 16, 2008 SUBJECT: RTOG 0627, Dose Levels Amended Amended RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme" Amendment 3: Dose Levels -3 and -4 were added to allow patients experiencing toxicity at Dose Level -2 to continue to receive protocol treatment. Please see the complete summary of changes at http://www.rtog.org/members/protocols/0627/summary_changes.html. Sites can download a copy of the protocol for IRB review by accessing the RTOG website at http://www.rtog.org/members/protocols/0627/0627.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 are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 11, 2008 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB CETUXIMAB *** Please note there is an error on the CARES Form that lists the attached Safety report as a Expedited Safety Report #2. It has been confirmed with BMS that this is an Initial Report. Please make a note of this. Thanks. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. - dasatinib-ib07-esr02.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 6, 2008 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. - dasatinib-ib07-esr01.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 8, 2008 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. - BMS-354825-1452957-7792-FU1 (2).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, 14, 2008 SUBJECT: RTOG 0627: Web data entry restored for F1 form ATTENTION: Institutions participating in RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme" Submission of the F1 form for RTOG 0627 via web data entry was temporarily unavailable, but it is now accessible again. Sites will submit the F1 form electronically. Paper versions will not be accepted and will be returned to the institution. Please notify your affiliates that are not on e-mail. DATE: January, 11, 2008 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. - BMS-354825-1452957.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 13, 2007 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. - dasatinib-ib06-esr09.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 7, 2007 SUBJECT: Temporary Suspension of Web Data Entry of the F1 Form for RTOG 0627 ATTENTION!!! ATTENTION!!! ALL PARTICIPATING INSTITUTIONS FOR RTOG 0627 Submission of the F1 form for this study via web data entry is temporarily unavailable. Please hold off submitting this form until you are notified via an RTOG Broadcast that it is again available for web data entry. Thank you. Web registration is available 24/7. Information and instructions available at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: November 01, 2007 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. - bms-354825-ib06-esr08.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 12, 2007 SUBJECT: RTOG 0627, First Patient Cohort to Close Today at 5 PM EST First Patient Cohort to Close Today at 5 PM EST As broadcast yesterday, the first cohort of RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme," has met accrual. Accrual will close today at 5 PM EST. Accrual to this protocol will be suspended while data from the first cohort is analyzed to determine whether there is sufficient evidence of response to proceed to the second stage of accrual. A broadcast will be sent when this decision has been made. 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 DATE: October 11, 2007 SUBJECT: RTOG 0627, First Patient Cohort to Close 10/12, 5 PM EST First Patient Cohort to Close Friday 10/12 at 5 PM EST The first cohort of RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme," has met accrual. Accrual will close at 5 PM EST on Friday 10/12. Accrual to this protocol will be suspended while data from the first cohort is analyzed to determine whether there is sufficient evidence of response to proceed to the second stage of accrual. A broadcast will be sent when this decision has been made. 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 DATE: October 10, 2007 SUBJECT:RTOG 0627, Accrual Still Open to First Patient Cohor Timeframe Extended for Closure of First Patient Cohort The first cohort of RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme," has not met accrual. At this time, a place for 1 additional patient remains. Accrual will be re-evaluated on Wednesday, October 17. If it has been met, accrual to the cohort will close at 5 PM EST on Friday, October 19. A broadcast with updated information will be sent on October 17. REMINDER: As specified in Section 10.2 of the protocol, the anticipated turnaround time from receipt of tissue to determination of molecular profile is approximately 1 week. Please consider the 1-week turnaround time when screening patients for enrollment. 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. DATE: September 28, 2007 SUBJECT: RTOG 0627, TIMEFRAME EXTENDED for Closure of First Patient Cohort Timeframe Extended for Closure of First Patient Cohort The first cohort of RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme," will NOT close to patient accrual at 5 PM EST today as previously anticipated. At this time, places for 2 additional patients remain. Accrual will be re-evaluated on Wednesday, October 10. If it has been met, accrual to the cohort will close at 5 PM EST on Friday, October 12. A broadcast with updated information will be sent on October 10. REMINDER: As specified in Section 10.2 of the protocol, the anticipated turnaround time from receipt of tissue to determination of molecular profile is approximately 1 week. Please consider the 1-week turnaround time when screening patients for enrollment. DATE: September 28, 2007 SUBJECT: RTOG 0627, Closure of First Patient Cohort Closure of First Patient Cohort As broadcast on September 21, the first cohort of RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme," will close to patient accrual at 5 PM EST today, because it is anticipated to have met the required number of patients by that time. Accrual to this protocol will be suspended while data from the first cohort is analyzed to determine whether there is sufficient evidence of response to proceed to the second stage of accrual. A broadcast will be sent when this decision has been made. 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://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: September 21, 2007 SUBJECT: RTOG 0627, Closure of First Patient Cohort Closure of First Patient Cohort The first cohort of RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme," will close to patient accrual at 5 PM EST on Friday, September 28, because it is anticipated to have met the required number of patients by that time. Accrual to this protocol will be suspended while data from the first cohort is analyzed to determine whether there is sufficient evidence of response to proceed to the second stage of accrual. A broadcast will be sent when this decision has been made. 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://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: September 20, 2007 SUBJECT: RTOG 0627, Amended Amended RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme" Amendment 2: Sections 3, 7, and 9 were amended to allow patients to receive antithrombotic, antiplatelet, and/or anti-inflammatory agents in a restricted fashion. Please see the complete summary of changes at http://www.rtog.org/members/protocols/0627/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/0627/0627.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://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: August 29, 2007 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB The Following RTOG studies involve DASATINIB: RTOG 0627 “PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME” 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. - dasatinib-ib06-esr03-fu01.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://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 15, 2007 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB The Following RTOG studies involve DASATINIB: RTOG 0627"PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. - dasatinib-ib06-esr07.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://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 31, 2007 SUBJECT: RTOG 0627, Amended and Updated Amended and Updated RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme" Amendment 1: Section 10 was rewritten to more clearly describe tissue submission logistics for the first 27 eligible patients and for patients 28 through study closure. Changes were also made to the Cover Page, Eligibility Checklist, Section 3, and Appendix I. Please see the complete summary of changes at http://www.rtog.org/members/protocols/0627/summary_changes.html. Update: Numbering was corrected on the Eligibility Checklist. Please see the complete summary of changes at http://www.rtog.org/members/protocols/0627/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/0627/0627.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. The "Update Date" indicates that editorial/administrative changes were made to the protocol after NCI approved the amendment. NCI requires that these changes be documented on the protocol title page as an update, not as an amendment. IRB review of an update is not required; however, these changes must be reported to site IRBs. 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://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 8, 2007 SUBJECT: RTOG 0627 Protocol Notice: BMS and/or NCI SAFETY REPORT FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for Dasatinib The Following RTOG study(s) involve Dasatinib (IND 73969): RTOG 0627 “PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME” 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. - BMS-354825 IB06 ESR06.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://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 2, 2007 SUBJECT: RTOG 0627: Important Information About Tissue Submission Attention Investigators Preparing to Enroll Patients on RTOG 0627: If the patient HAS NOT undergone central pathology review through enrollment on another RTOG GBM trial, please submit tissue directly to Dr. Aldape at the address below. Ken Aldape, MD Department of Pathology, Box 85 Room G1.3595C UT-MD Anderson Cancer Center 1515 Holcombe Blvd Houston, TX 77030 (713) 792-0634 FAX (713) 792-4049 kaldape@mdanderson.org If the patient HAS undergone central pathology review through enrollment on another RTOG GBM trial, please contact the RTOG Tissue Bank at the address below. The Tissue Bank will forward any needed material to Dr. Aldape. LDS Hospital RTOG Tissue Bank, 1st Floor North 8th Avenue C Street Salt Lake City, UT 84143 (801) 408-5626; (801) 408-2035 FAX (801) 408-5020 RTOG@intermountainmail.org Until you are otherwise notified (via broadcast or amended protocol), TISSUE FOR ALL PATIENTS MUST BE SUBMITTED PRIOR TO REGISTRATION. After reviewing the tissue, Dr. Aldape will email the P6 form to the institution. If the patient over-expresses at least 2 dasatinib targets, the patient can be registered to the trial. The protocol will be amended in the near future to reflect these modified logistics. Please notify your affiliates who 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://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 26, 2007 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" 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. - BMS-354825 IB06 ESR05.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://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 15, 2007 SUBJECT: Updated Version of A5 Forms for RTOG 0525, 0615, 0625 and 0627 Updated Version of A5 Forms for RTOG 0525, 0615, 0625 and 0627. The A5 (demographic form) for the following studies: 0525, 0615, 0625 and 0627 has been updated to version 2.1. Changes Made: Changes have been made in Questions 2A&2B with regard to the designations for race and ethnic group categories. Please discard obsolete versions and commence use of this new version immediately. Please notify your joint centers and affiliates who are not on e-mail. RTOG Data Management DATE: January 29, 2007 SUBJECT: RTOG 0627 - "Phase II Trial of Dasatinib in Patients with Recurrent Glioblastoma Multiforme" RTOG 0627 Forms for this Phase II GBM study have been posted on the RTOG web site. They are available at the following link: DATE: January 24, 2007 SUBJECT: RTOG 0627, Activated Activated RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme" You may download a copy of the protocol for IRB review by accessing the RTOG website at http://www.rtog.org/members/protocols/0627/0627.pdf. Forms for this study will posted on the RTOG website by the week of January 29. At the time of that posting, a broadcast with the forms link will be sent. Forms for this study will posted on the RTOG website by the week of January 29. At the time of that posting, a broadcast with the forms link will be sent. Forms for this study will posted on the RTOG website by the week of January 29. At the time of that posting, a broadcast with the forms link will be sent. Regulatory Notes: NCI policy requires that the "Version Date" of the protocol reflect the date that the protocol was submitted by RTOG to NCI; therefore, the version date and the activation date on the protocol title page are not the same. The "Update Date" (the same as the activation date) indicates that minor administrative changes were made to the protocol after NCI approval; these changes are detailed in a summary of changes that can be accessed at http://www.rtog.org/members/protocols/0627/summary_changes.html. Please notify your affiliates who 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://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html