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

Alternate Title

Phase II Randomized Study of Topical Halofuginone Hydrobromide in Patients With HIV-Related Kaposi's Sarcoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	16 and over	NCI	AMC-036 CWRU-040332, NCT00064142

Special Category: NCI Web site featured trial

Trial Description

Purpose:

Topical halofuginone hydrobromide ointment may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.

This randomized phase II trial is studying how well topical halofuginone hydrobromide works in treating patients with HIV -related Kaposi's sarcoma.

Eligibility:

Eligibility criteria include the following:

• At least 16 years old
• Have at least 14 Kaposi's sarcoma skin lesions
• Measurable disease
• More than 4 weeks since biological therapy, chemotherapy, or radiation therapy for Kaposi's sarcoma
• 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:

Twelve lesions on each patient will be treated. Patients will apply topical halofuginone hydrobromide ointment to six randomly-assigned lesions twice a day for 12 weeks. They will also apply a placebo ointment to six other lesions twice a day for 12 weeks.

Patients who have stable or responding disease may receive additional treatment with topical halofuginone hydrobromide ointment to all 12 lesions for another 12 weeks.

Patients will be evaluated periodically for at least 1 month after treatment.

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

AIDS Associated Malignancies Clinical Trials Consortium

Susan Krown, MD, Protocol chair		Ph: 212-639-7426; 800-525-2225 Email: krowns@mskcc.org
Henry Koon, MD, Protocol co-chair		Ph: 617-667-9900
Merrill Egorin, MD, Protocol co-chair		Ph: 412-623-3252 Email: egorinmj@msx.upmc.edu

Related Information

Featured trial article

Registry Information
Official Title		A Phase II Trial of Topical Halofuginone in Patients with HIV Related Kaposi's Sarcoma
Trial Start Date		2003-05-20
Trial Completion Date		2008-03-13
Registered in ClinicalTrials.gov		NCT00064142
Date Submitted to PDQ		2003-05-22
Information Last Verified		2006-01-03
NCI Grant/Contract Number		CA70019

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