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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 Thalidomide, Celecoxib, Etoposide, and Cyclophosphamide in Patients With Relapsed or Refractory Malignant Glioma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	DFCI-01278 NCI-G02-2117, CELGENE-2001-P-001757/3, NCT00047281

Trial Description

Purpose:

Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide and celecoxib with etoposide and cyclophosphamide may kill more tumor cells.

Phase II trial to study the effectiveness of combining thalidomide and celecoxib with etoposide and cyclophosphamide in treating patients who have relapsed or refractory malignant glioma.

Eligibility:

• At least 18 years old
• Not pregnant or nursing
• No more than 2 months of treatment with thalidomide, celecoxib, etoposide, or cyclophosphamide taken by mouth
• At least 4 weeks since radiation therapy
• 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 thalidomide by mouth once a day and celecoxib by mouth twice a day for 6 weeks. They will also receive etoposide by mouth once a day for 3 weeks followed by cyclophosphamide by mouth once a day for 3 weeks. Treatment may be repeated every 6 weeks for as long as benefit is shown. Patients will be evaluated every 2 months.

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

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Patrick Wen, MD, Protocol chair		Ph: 617-632-2166; 866-790-4500 Email: patrick_wen@dfci.harvard.edu

Registry Information
Official Title		Trial Of Oral Thalidomide, Celecoxib, Etoposide And Cyclophosphamide In Adult Patients With Relapsed Or Progressive Malignant Gliomas
Trial Start Date		2002-03-18
Registered in ClinicalTrials.gov		NCT00047281
Date Submitted to PDQ		2002-08-26
Information Last Verified		2004-11-08
NCI Grant/Contract Number		P30-CA06516

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