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

Alternate Title

Phase II Study of Vorinostat (SAHA) and Bortezomib in Patients With Progressive, Recurrent Glioblastoma Multiforme

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Closed	18 and over	NCI	NCCTG-N0779 N0779, NCT00641706

Trial Description

Purpose:

Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more tumor cells.

This phase II trial is studying how well giving vorinostat together with bortezomib works in treating patients with progressive, recurrent glioblastoma multiforme.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable or evaluable disease
• At least 8 weeks since radiation therapy
• More than 4 weeks since chemotherapy
• More than 4 weeks since bevacizumab
• No previous vorinostat or bortezomib
• 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 be assigned to one of two treatment groups.

Patients in group one will receive vorinostat by mouth once a day for 2 weeks. They will also receive an infusion of bortezomib twice a week for 2 weeks. Treatment may repeat every 3 weeks for as long as benefit is shown.

Patients in group two will receive vorinostat by mouth once a day for 2 days before surgery and on the day of surgery. They will also receive an infusion of bortezomib on the day of surgery. Patients will then undergo surgery to remove the tumor. Beginning at least 1 week after surgery, patients will receive vorinostat by mouth once a day for 2 weeks and an infusion of bortezomib twice a week for 2 weeks. Treatment may repeat every 3 weeks for as long as benefit is shown.

Tumor tissue samples will be collected at the beginning of the study for laboratory studies. Tumor tissue samples may also be collected during surgery.

After finishing treatment, patients will be evaluated every 3 months for 2 years and every 6 months thereafter.

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: 507-284-2511

Registry Information
Official Title		Phase II Study of Vorinostat (SAHA) in Combination with Bortezomib (PS-341) in Patients with Recurrent Glioblastoma Multiforme
Trial Start Date		2008-07-04
Trial Completion Date		2009-08-01 (estimated)
Registered in ClinicalTrials.gov		NCT00641706
Date Submitted to PDQ		2008-03-13
Information Last Verified		2010-01-29
NCI Grant/Contract Number		CA25224

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