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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 Sulindac and Tamoxifen in Patients With Desmoid Tumor That is Recurrent or Not Amenable to Standard Therapy

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Temporarily closed	18 and under at original diagnosis	NCI	COG-ARST0321 NCT00068419, ARST0321

Trial Description

Purpose:

Sulindac may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Hormone therapy using tamoxifen may fight cancer by blocking the use of estrogen. Combining sulindac with tamoxifen may kill more cancer cells.

This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor.

Eligibility:

Eligibility criteria include the following:

• Younger than 19 years old at diagnosis
• Measurable disease
• At least 1 week since biological therapy
• At least 6 months since donor stem cell transplantation
• At least 2 weeks since 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 sulindac and tamoxifen by mouth twice a day. Treatment may continue for up to 1 year. After finishing treatment, patients will be evaluated for 5 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

Children's Oncology Group

Steve Skapek, MD, Protocol chair		Ph: 773-834-3508901; 800-289-6333
R. Beverly Raney, MD, Protocol co-chair(Contact information may not be current)		Ph: 361-694-5766; 800-324-5683

Registry Information
Official Title		A Phase II Study of Sulindac and Tamoxifen in Patients with Desmoid Tumors that are Recurrent or Not Amenable to Standard Therapy
Trial Start Date		2004-02-16
Trial Completion Date		2009-10-05 (estimated)
Registered in ClinicalTrials.gov		NCT00068419
Date Submitted to PDQ		2003-07-18
Information Last Verified		2009-07-28
NCI Grant/Contract Number		CA98543

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