SUMMARY OF CHANGES
Amendment #3, Version Date: May 8, 2008
(Broadcast May 16, 2008)
RTOG 0627, Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme
Study Chair: Andrew B. Lassman, MD; 212-639-6037; lassmana@mskcc.org
To allow patients experiencing toxicity at Dose Level -2 to continue to receive protocol treatment, RTOG 0627 has been amended to include the following additional dose levels:
- Dose level -3: two 50-mg dasatinib tablets daily simultaneously (a regimen associated with less toxicity than twice-daily dosing); and
- Dose level -4: one 50-mg dasatinib tablet and one 20-mg tablet daily simultaneously.
Specific changes were made to the following sections:
- Section 7.2: Under "How Supplied,"
- The first bullet was added to provide information concerning the 20-mg tablet.
- The second bullet was updated to include "(or 'BMS' on one side and '528' on the other side)."
- Section 7.3:
- 2nd paragraph, last sentence: Reference was added to dose levels -3 and -4.
- Table: Dose levels -3 and -4 were added.
SUMMARY OF CHANGES
Amendment #2, Version Date: September 5, 2007
RTOG 0627, Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme
Study Chair: Andrew B. Lassman, MD; 212-639-6037; lassmana@mskcc.org
To allow patients to receive antithrombotic, antiplatelet, and/or anti-inflammatory agents in a restricted fashion if they develop a problem during the study (e.g., deep vein thrombosis, angina, myocardial infarction, etc.) that is felt to be unrelated or unlikely to be related to protocol treatment, RTOG 0627 has been amended as follows:
Sections 3.2.8: This criterion was rewritten to be consistent with the changes made to Section 9.2.3 (see below). The criterion now reads, "Use of antithrombotic and/or antiplatelet agents (e.g., warfarin, heparin, low molecular weight heparin, aspirin, clopidogrel, ticlopidine, Aggrenox). See also 9.2.3.
Section 3.2.9: This criterion was rewritten to be consistent with the changes made to Section 9.2.3.1 (see below). The criterion now reads, "Use of ibuprofen and other NSAIDs. See also 9.2.3.1." The corresponding change to Eligibility Checklist page 3, question 24 was also made.
Section 7.2: Under "Potential Drug Interactions", the last sentence was rewritten to be consistent with the changes made to Section 9.2.3-9.2.3.1 (see below). The criterion now reads, "Due to the possibility of gastrointestinal, cardiac, and cutaneous hemorrhage, medications that inhibit platelet function or anticoagulants with BMS-354825 should only be used with caution if clearly medically indicated (see 9.2.3 and 9.2.3.1)."
Section 9.2.3:
- The second sentence was rewritten to indicate that patients may not be taking anticoagulants and medications that inhibit antiplatelet function at the time of study entry, and the list of possible agents in this category was expanded. The sentence now reads, "For this reason, patients may not be taking anticoagulants or medications that inhibit platelet function at study entry, including but not limited to warfarin, heparin, aspirin, clopidogrel, ticlopidine, and Aggrenox.
- The last two sentences were added to allow patients to receive anticoagulants and medications that inhibit platelet function if used with caution if medically indicated due to a problem that is felt to be unrelated or unlikely to be related to dasatinib.
Section 9.2.3.1: This section was added in light of the changes described above to more specifically detail that patients are permitted to receive ibuprofen and other NSAIDs if used with caution and if medically indicated as described above.
SUMMARY OF CHANGES
Update Date: May 31, 2007
RTOG 0627, Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme
Study Chair: Andrew B. Lassman, MD; 212-639-6037; lassmana@mskcc.org
RTOG 0627 has been updated as follows:
Eligibility Checklist page 3, question 32: The numbering was corrected from #33 to #32.
NOTE: These are editorial/administrative changes to the protocol. NCI now requires that these changes be documented on the protocol title page with the date of the update noted as "Update Date," not as an amendment.
An updated protocol is available on the RTOG website: www.rtog.org
SUMMARY OF CHANGES
Amendment #1, Version Date: May 18, 2007
RTOG 0627, Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme
Study Chair: Andrew B. Lassman, MD; 212-639-6037; lassmana@mskcc.org
RTOG 0627 has been amended as follows:
Cover Page: The phone number for Dr. Gilbert and the fax number for Dr. Aldape have been updated. In addition, the activation date has been added per RTOG standard.
Eligibility Checklist page 1, question 1: Gliosarcoma was added as a possible diagnosis per Section 3.1.1.
Eligibility Checklist page 1, question 10: The sub-question was added to clarify that patients are ineligible if they have received prior therapy other than radiotherapy and temozolomide.
Eligibility Checklist page 3, question 26: "including Gamma-Knife, Cyberknife, or other variants" was added parenthetically to qualify stereotactic radiosurgery for increased clarity.
Section 3.1.1: The second sentence was added to clarify that patients with gliosarcoma are eligible.
Section 3.1.11:"including Gamma-Knife, Cyberknife, or other variants" was added parenthetically to qualify stereotactic radiosurgery for increased clarity.
Section 10: The entire section was rewritten to more clearly describe tissue submission logistics for the first 27 eligible patients and for patients 28 through study closure.
Appendix I, "Before you begin the study," last paragraph
- In the third sentence, "to not be affected" was corrected to "not to be affected."
- The last two sentences were re-written for increased clarity.
SUMMARY OF CHANGES
Update Date: January 24, 2007
RTOG 0627, Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme
Study Chair: Andrew B. Lassman, MD; 212-639-6037; lassmana@mskcc.org
RTOG 0627 has been updated as follows:
Cover page: New phone number for Dr. Aldape
Section 10.3.6.1:
First sentence: P3 form corrected to P6
Second sentence: Re-written for increased clarity
Section 13: Formatting corrected
Section 13.4.2: Numbering of sub-sections corrected
In addition, the following text was updated to reflect Bristol-Myers Squibb's most recent dasatinib-related information:
Section 7.1.2: Second bullet
Section 7.2: Method of Administration, first sentence; Special Handling, entire section
Appendix I/Sample Consent: During the Study, second paragraph, second sentence: Added for consistency with the protocol
NOTE: These are editorial/administrative changes to the protocol. NCI now requires that these changes be documented on the protocol title page with the date of the update noted as "Update Date," not as an amendment.
An updated protocol is available on the RTOG website: www.rtog.org