1. Primary Glioblastoma Multiforme (NLD: primair Glioblastoma multiforme),
Conditions
Interventions
Study population will be treated with standard GBM chemoradiotherapy schedule plus additional 3 infusions of the angiogenesis inhibitor bevacizumab at a dose of 10 mg/kg during irradiation (e.g. one d
Sponsors
Departments of Neurosurgery, Radiation Oncology, Clinical Oncology and Neurology
Academisch Medisch Centrum
Meibergdreef 15
1105 AZ Amsterdam
+31 20 5669111
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with histologically proven GBM (biopsy or resection); 2. Can start 3-8 weeks post biopsy or surgery; 3. Mini-Mental Status Score >15; 4. Karnofsky >60; 5. Adequate bone marrow function; 6. Informed consent.
Exclusion criteria
Exclusion criteria: 1. Age <18 years; 2. Pregnancy; 3. Reluctance to use contraceptives; 4. Inability to comply with protocol or study procedures (for example, an inability to swallow tablets); 5. Bleeding disorders; 6. Anti-coagulant therapy; 7. Prior chemotherapy or radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective is determination of safety of combination of standard treatment with 3 bevacizumab infusions, followed by the standard adjuvant cycles of temozolomide. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: determination of: 1. efficacy; 2. classical response end-points; 3. tumor imaging biomarkers; 4. tissue samples biomarkers. | — |
Contacts
Public ContactW.R. Furth van
Academisch Medisch Centrum Meibergdreef 15
Outcome results
None listed