Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II study of the combination of Avastin and metronomic temozolomide in recurrent malignant glioma patients. The primary objective will be to determine the efficacy of Avastin (bevacizumab) and metronomic temozolomide in malignant glioma patients. The secondary objective will be to determine the safety of Avastin, 10 mg/kg every other week, in combination with metronomic temozolomide in terms of progression-free survival.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborators: Genentech, Inc.; Schering-Plough
• Treatments: Bevacizumab; Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• Patients must have histologically confirmed diagnosis of WHO grade IV primary malignant glioma

• Karnofsy Performance Status (KPS) >/= 60%

• Evidence of measurable primary CNS neoplasm on contrast-enhanced MRI.

• An interval of at least 4 weeks between prior surgical resection or 1 week from a biopsy and enrollment on this protocol

• An interval of at least 4 weeks from the end of prior radiotherapy or one week from the end of a cycle of chemotherapy and enrollment on this protocol.

• No evidence of CNS hemorrhage on the baseline MRI or CT scans

Exclusion Criteria:

• Life expectancy < 8 weeks

• Pregnancy or breast feeding

• Progression to metronomic temozolomide, defined as tumor progression while taking daily temozolomide or progression within 4 weeks of stopping metronomic temozolomide

• Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)