NCT01086345

Radiosurgery Plus Bevacizumab in Glioblastoma

Phase I/II Trial of Radiosurgery Plus Bevacizumab in Patients With Recurrent/Progressive Glioblastoma

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. 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 glioblastoma by blocking blood flow to the tumor. Drugs used in chemotherapy such as irinotecan hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiosurgery together with bevacizumab and irinotecan hydrochloride may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving radiosurgery together with bevacizumab and irinotecan hydrochloride works in treating patients with recurrent glioblastoma.

Detailed description

PRIMARY OBJECTIVES: I. To determine the overall survival of patients with recurrent GBM treated with bevacizumab, irinotecan and radiosurgery SECONDARY OBJECTIVES: I. To evaluate the toxicities of the combination of bevacizumab, irinotecan and radiosurgery. II. To evaluate the progression-free survival of patients treated with bevacizumab, irinotecan and radiosurgery. OUTLINE: Patients receive bevacizumab IV over 30 minutes on days 1 and 15. Patients also receive irinotecan hydrochloride IV on days 1 and 15 beginning in course 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiosurgery 10-14 days after beginning bevacizumab. After completion of study treatment, patients are followed for 18 months.

Conditions

• Glioblastoma
• Gliosarcoma
• Brain Tumor

Interventions

Type	Name	Description
RADIATION	radiosurgery	Patients undergo radiosurgery 10-14 days after beginning bevacizumab.
BIOLOGICAL	bevacizumab	Given IV
DRUG	irinotecan hydrochloride	Given IV

Timeline

• Start date: 2010-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2010-03-15
• Last updated: 2018-07-03

Locations

1 site across 1 country: United States