Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas

PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2012

Conditions
GlioblastomaGliosarcoma
Interventions
DRUG

Avastin and Temozolomide

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.

Trial Locations (1)

27710

Duke University Health System, Durham

Sponsors
All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

Schering-Plough

INDUSTRY

lead

Duke University

OTHER

NCT00612339 - Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas | Biotech Hunter | Biotech Hunter