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Clinical Trials/NCT00337207
NCT00337207CompletedPhase 2

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

Northwestern University4 sites in 1 country55 target enrollmentStarted: March 2006Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
55
Locations
4
Primary Endpoint
Progression-free Survival at 6 Months

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Progression-free Survival at 6 Months

Time Frame: 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

Time Frame: 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

Time Frame: Before and after treatment

To assess changes in tumoral blood flow based on MR Perfusion and tissue changes by MR spectroscopy.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeffrey Raizer

Jeffrey Raizer, MD

Northwestern University

Study Sites (4)

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