At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Avastin in Combination With Temozolomide for Unresectable or Multifocal Glioblastoma Multiformes and Gliosarcomas
In Brief
A Phase 2 clinical trial evaluating Avastin and Temozolomide for Glioblastoma and Gliosarcoma. Completed, enrolled 41 participants across 1 site.
Detailed Summary
Primary objective- To determine efficacy of Avastin, 10 mg/kg every other week, in combination with standard 5-day temozolomide in terms of response rate. Secondary objective- To determine safety of Avastin \& Temozolomide in unresectable glioblastoma patients
Study Details
Timeline
Interventions
This is Phase II study with the combination of Avastin \& Temozolomide for unresectable or multifocal WHO grade IV malignant glioma patients. Patients will receive up to 4 cycles of Avastin \& Temozolomide . Avastin administered at 10 mg/kg every 14 days beginning minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide will be dosed at 200 mg/m2 daily x 5 days in 28-day cycle. Patients will have baseline MRI \& repeat MRI every 4 weeks. If there is no evidence of disease progression after each cycle, or unacceptable toxicity, or as determined by investigators, patient non-compliance or patient withdraws consent to continue therapy \& requests discontinuation, patients will receive up to 4 cycles of Avastin \& Temozolomide, then proceed with standard XRT therapy, \& future therapy after 4 cycles will be at discretion of patient \& treating physicians.