NCT00612339

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

Avastin in Combination With Temozolomide for Unresectable or Multifocal Glioblastoma Multiformes and Gliosarcomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Subjects have histologically confirmed WHO gr IV primary malignant glioma that is unresectable/multifocal. This is Phase II study where up to 41 subjects will receive up to 4 cycles of Avastin \& Temozolomide. Avastin administered at 10 mg/kg every 14 days beginning a minimum of 7 days after biopsy/28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in 28-day cycle. Patients will receive up to 4 cycles of Avastin \& Temozolomide, then proceed with standard XRT. Study will use 2-stage "minimax" study design in which 21 subjects are accrued during 1st stage, with possibility that additional 20 patients accrued during 2nd stage. In initial Phase I \& II trials, 4 potential Avastin-associated safety signals were identified: hypertension, proteinuria, thromboembolic events, \& hemorrhage. Avastin-associated adverse events in Phase III trials include congestive heart failure, GI perforations, wound healing complications, \& arterial thromboembolic events. Most common toxicity associated with Temozolomide has been mild myelosuppression.

Conditions

• Glioblastoma
• Gliosarcoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-08-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2008-02-11
• Last updated: 2013-05-27
• Results posted: 2012-09-10

Locations

1 site across 1 country: United States