NCT00337207

Bevacizumab in Treating Patients With Recurrent or Progressive Glioma

A Phase II Safety Study of Bevacizumab in Patients With Multiple Recurrent or Progressive Malignant Gliomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with recurrent or progressive glioma.

Detailed description

OBJECTIVES: * Determine the safety of single-agent bevacizumab in the treatment of patients with recurrent or progressive malignant glioma. * Determine the efficacy of bevacizumab, in terms of progression-free survival at 6 months, in these patients. * Assess changes in tumoral blood flow based on magnetic resonance (MR) perfusion and tissue changes by MR spectroscopy. OUTLINE: This is a pilot study. Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab	Bevacizumab 15 mg/kg every 3 weeks over 30 to 90 minutes. One cycle = 3 weeks. Treatment continues until progressive disease or unacceptable toxicity.

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-11-01
• Completion: 2009-05-01
• First posted: 2006-06-15
• Last updated: 2020-02-07
• Results posted: 2012-11-19

Locations

2 sites across 1 country: United States