At a glance
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Avastin in Combination With Temozolomide and Irinotecan for Unresectable or Multifocal Glioblastoma Multiformes and Gliosarcomas
In Brief
A Phase 2 clinical trial evaluating Avastin, Temozolomide, and 1 other intervention for Glioblastoma Multiforme and Gliosarcoma. Completed, enrolled 41 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Avastin, by intravenous infusion, 10 mg/kg every 14 days
Oral temozolomide at 200 mg/m2 daily for 5 days
Irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)