NCT00268359

Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas

Bevacizumab in Combination With Irinotecan for Malignant Gliomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Duke 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. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with irinotecan may kill more tumors cells. PURPOSE: This phase II trial is studying the side effects of bevacizumab and how well giving bevacizumab together with irinotecan works in treating patients with recurrent or refractory gliomas.

Detailed description

OBJECTIVES: Primary * Determine the safety of bevacizumab and irinotecan hydrochloride in patients with recurrent or refractory grade 3 or 4 malignant gliomas. Secondary * Determine the activity of this regimen, in terms of progression-free survival, in these patients. OUTLINE: Patients receive bevacizumab and irinotecan hydrochloride every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab
DRUG	irinotecan hydrochloride

Timeline

• Start date: 2005-05-01
• Primary completion: 2006-08-01
• Completion: 2009-10-01
• First posted: 2005-12-22
• Last updated: 2014-07-21

Locations

1 site across 1 country: United States