Conditions: Glioblastoma Multiforme
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 91
Healthy volunteers: no

Brief summary:
This randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment arms. The anticipated time of study treatment is until disease progression or unacceptable toxicity.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: bevacizumab [Avastin] intervention 2: fotemustine
Intervention descriptions: intervention 1: 10 mg/kg every 2 weeks intravenously until disease progression or unacceptable toxicity intervention 2: 75 mg/m2 intravenously on days 1, 8 and 15 followed by, after a 5 weeks interval, 100 mg/m2 on day 1 of a 3-weeks cycle. Until disease progression or unacceptable toxicity

Protocol document: