The Preston Robert Tisch Brain Tumor Center at Duke

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.

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