Clinical Trials for Adults | Phase II Trial of Bevacizumab, Radiation Therapy and Temodar followed by Bevacizumab and Temodar with Continuation of Bevacizumab Beyond Progression (BBP-Bevacizumab Beyond Progression)
Eligibility: Key Criteria
- Adult newly diagnosed WHO grade IV GBM or gliosarcoma
- Must be no more than 8 weeks from surgical procedure.
- KPS > 60%
- No evidence of > Grade 1 CNS hemorrhage or higher on baseline MRI.
- If history of HTN, must be controlled (defined as >150/100)
- No prior treatment for brain tumor, including Gliadel
- No prior Avastin, for any condition
- No prior history of GI perforation or abscess
- Any previous venous thromboembolism > Grade 3 (Ex. life threatening, PE, cerebrovascular event).
Study Design: Key Features
The protocol is comprised of four parts:
- During part A, patients will receive:
- Daily standard XRT starting a minimum of 2weeks after resection
- Daily Temozolomide at a dose of 75mg/m2
- Avastin at a dose of 10mg/kg every other week starting a minimum of four weeks after resection
- During part B, patients will receive:
- Temozolomide at a dose of 200mg/m2 (Day 1 through 5) and
- Avastin every other week (Day 1 and 15) at a dose of 10mg/kg
- During Part C, patients will receive:
- Avastin at a dose of 10mg/kq every other week or 15mg/kg every 3 weeks
- During Part D, patients will receive:
- An Avastin-based regimen determined by their BTC attending physician
*If a patient progresses in part B or part C, they will go to part D. This will consist of an Avastin-based regimen that will be decided upon by the patient’s BTC attending physician. Part D cannot be in conjunction with another clinical trial.
- Avastin will be provided by Genentech. Temodar will NOT be provided.
- Treatment cycles (during parts B and C) are 28 days continuously, and patients will receive up to 12 cycles.
- Patients will answer QOL questionnaires, and perform CNS vital signs and the 6 minute walk test at baseline, post XRT, and then every 6 months thereafter.
- 68 patients will be enrolled.