Conditions: Glioblastoma Multiforme
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 32
Healthy volunteers: no

Brief summary:
This is a Phase II, national, multicenter, open-label, non-comparative study to investigate the efficacy and safety of bevacizumab and temozolomide in patients with recurrent glioblastoma multiforme (GBM) after a first treatment failure. Patients will receive bevacizumab 10 mg/kg intravenously every two weeks until disease progression, consent withdrawal, or unacceptable toxicity. Anticipated time on study treatment is 12-24 months.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: bevacizumab [Avastin] intervention 2: temozolomide
Intervention descriptions: intervention 1: Bevacizumab 10 mg/kg body weight will be administered intravenously every two weeks intervention 2: Daily by the oral route (dose, 150 mg/m2) on days 1 to 7 and 15 to 21 of each cycle

Protocol document: