Avastin/Temozolomide/Irinotecan for Unresectable/Multifocal Glioblastoma Multiforme
Summary
The primary objective of the study is to determine the efficacy of Avastin in combination with temozolomide and irinotecan in terms of response rate. The secondary objectives are to describe the overall and progression-free survivals of unresectable patients treated with upfront Avastin, temozolomide and irinotecan and to assess the safety of Avastin, temozolomide and irinotecan in unresectable glioblastoma patients. This is a phase II study with the combination of Avastin, temozolomide and irinotecan for unresectable or multifocal World Health Organization (WHO) grade IV malignant glioma patients. Patients will receive up to four cycles of Avastin, temozolomide and irinotecan. Approximately 41 subjects will take part in this study at Duke.
Timeline
- Start
- 2009-11
- Primary completion
- 2011-02
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Irinotecan | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 125 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 275 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 340 mg/m2 | Intravenous |
| Subject | Temozolomide | Small molecule | 200 mg/m2 | Oral |