Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of Bevacizumab and Sorafenib in Patients With Recurrent Glioblastoma Multiforme

Basic Trial Information

Trial Description

Purpose:

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. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with sorafenib may kill more tumor cells.

This phase II trial is studying the side effects and how well giving bevacizumab together with sorafenib works in treating patients with recurrent glioblastoma multiforme.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable or evaluable disease
• At least 12 weeks since radiation therapy
• More than 4 weeks since chemotherapy, surgery, or open biopsy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive sorafenib by mouth once a day on days 1-14. They will also receive a 30- to 90-minute infusion of bevacizumab on day 1. Treatment may repeat every 2 weeks for as long as benefit is shown.

Patients will undergo blood sample collection at the beginning of the study and periodically during treatment for laboratory studies.

Quality of life will be assessed at the beginning of the study, before every other treatment course, and at the end of treatment.

After finishing treatment, patients will be evaluated at 28-42 days, every 3 months for 5 years, and once a year for 10 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Evanthia Galanis, MD, Protocol chair		Ph: 507-284-3559

Registry Information
Official Title		Phase II Trial of Bevacizumab in Combination with Sorafenib in Recurrent Glioblastoma Multiforme
Trial Start Date		2008-09-12
Trial Completion Date		2009-02-03 (estimated)
Registered in ClinicalTrials.gov		NCT00621686
Date Submitted to PDQ		2008-02-12
Information Last Verified		2010-04-24
NCI Grant/Contract Number		CA25224

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