Radiosurgery Plus Bevacizumab in Glioblastoma

Early Phase 1

Terminated

• Conditions: Gliosarcoma; Brain Tumor; Glioblastoma
• Interventions: Radiation: radiosurgery; Biological: bevacizumab; Drug: irinotecan hydrochloride

• Registration Number: NCT01086345
• Lead Sponsor: Case Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	bevacizumab	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.
Arm I	radiosurgery	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.
Arm I	irinotecan hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
Overall survival of patients with recurrent GBM treated with bevacizumab, irinotecan and radiosurgery	Patients are followed for 18 months.

Secondary Outcome Measures

Name	Time	Method
Treatment-related toxicity	Courses repeat every 28 days in the absence of unacceptable toxicity.
Progression-free survival, defined as the interval from randomization to progression or death, whichever occurs first	Patients are followed for 18 months.

Trial Locations

Locations (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States