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Bevacizumab for Recurrent Malignant Glioma

NCT00271609 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2014-04-29

Study results available
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Summary

Background:

Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels in tumors. Inhibiting the formation of these blood vessels may slow or stop disease progression by diminishing the supply of life-sustaining nutrients and oxygen the blood delivers to the tumor.

Bevacizumab is approved for treating colorectal cancer and has shown activity against brain tumor cells in laboratory and animal tests.

Objectives:

To examine the safety and side effects of bevacizumab in patients with recurrent brain tumors.

To determine the anti-tumor activity of bevacizumab in patients with recurrent brain tumors.

Eligibility:

Patients 18 years of age and older with a brain tumor that continues to grow after receiving standard treatments.

Design:

Patients complete the following procedures during the study:

* Infusions of bevacizumab through a vein once every 2 weeks in 4-week treatment cycles.
* Positron emission tomography (PET) scan before the first dose of bevacizumab, at the end of the first treatment cycle, and as needed after that.
* Magnetic resonance imaging (MRI) scan before the first dose of bevacizumab, within 48-96 hours after the first dose of bevacizumab in the first treatment cycle, and then every 4 weeks. One tube of blood for research is collected at the time of each MRI scan to look at specific cells.
* Physical and neurological examinations every 2 weeks for the first treatment cycle and then every 4 weeks.
* Quality-of-life questionnaires every 4 weeks.

Conditions

  • Recurrent High-Grade Gliomas
  • Malignant Gliomas

Interventions

DRUG

Bevacizumab

10 mg/kg intravenously over 90 minutes every 2 weeks on a 28 day cycle. First dose is given over 90 minutes and subsequent doses are given over 30 minutes.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Teri Kreisl, M.D. · National Cancer Institute, National Institutes of Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2011-03-31
Completion
2014-02-28

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00271609 on ClinicalTrials.gov