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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 Adjuvant Temozolomide, Thalidomide, and Celecoxib After Radiotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	DFCI-00302 NCI-G02-2118, CELGENE-2000-P-002521/1, NCT00047294

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may increase the effectiveness of temozolomide by making tumor cells more sensitive to the drug.

Phase II trial to study the effectiveness of combining temozolomide, thalidomide, and celecoxib following radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

Eligibility:

• At least 18 years old
• Not pregnant or nursing
• No more than 5 weeks since completing radiation therapy
• No previous thalidomide
• No previous chemotherapy
• 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 temozolomide by mouth once a day on days 1-5. They will also receive thalidomide by mouth once a day and celecoxib by mouth twice a day for 4 weeks. Treatment may be repeated every 4 weeks for up to 24 courses. Patients will be evaluated periodically.

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		Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting
Trial Start Date		2002-04-17
Registered in ClinicalTrials.gov		NCT00047294
Date Submitted to PDQ		2002-08-26
Information Last Verified		2005-05-25
NCI Grant/Contract Number		P30-CA06516

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