Bevacizumab in Treating Patients With Recurrent or Progressive Glioma

Phase 2

Completed

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00337207
• Lead Sponsor: Northwestern University

Brief 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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-06-13
• Study First Submitted QC: 2006-06-13
• Study First Posted: 2006-06-15
• Primary Completion: 2008-11
• Study Completion: 2009-05
• Results First Submitted: 2012-10-21
• Results First Submitted QC: 2012-10-21
• Results First Posted: 2012-11-19
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression-free Survival at 6 Months	After all patients have surpassed the 6 month post-treatment timepoint	The number of patients experiencing progression free survival (PFS) was calculated at the 6-month time point.
Safety of Treatment	From treatment initiation, throughout treatment and up to 30 days post-treatment, for up to 1 year.	Safety of treatment will be defined by the number of patients that experience grade 3 and 4 adverse events where causal relationship with bevacizumab cannot be completely ruled out. Adverse events will be graded using Common Terminology Criteria for Adverse Events v3.0 (CTCAE) where: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Tumoral Blood Flow Changes	Before and after treatment	To assess changes in tumoral blood flow based on MR Perfusion and tissue changes by MR spectroscopy.

Trial Locations

Locations (2)

Hematology-Oncology Associates of Illinois; 🇺🇸 Chicago, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University; 🇺🇸 Chicago, Illinois, United States