Name of the Trial
Phase II Randomized Study of Topical Halofuginone Hydrobromide in Patients with HIV-Related Kaposi's Sarcoma (AMC-036). See the protocol summary at http://cancer.gov/clinicaltrials/AMC-036.

Principal Investigators
Dr. Susan E. Krown, Dr. Henry Koon, and Dr. Merrill Egorin, from the AIDS-Associated Malignancies Clinical Trials Consortium (AMC)

Why Is This Trial Important?
Kaposi's sarcoma is the most common cancer in patients infected with HIV, the virus that causes AIDS. Although various methods can be used to treat Kaposi's sarcoma, better and less toxic treatments are needed.

Laboratory studies have shown that halofuginone, an experimental drug, can block the growth and spread of certain cancer cells and can also block the flow of blood to tumors, a process called antiangiogenesis. Unlike other drugs used to treat Kaposi's sarcoma, which must be given by vein or by mouth, halofuginone may be effective when given as a cream or ointment and applied directly to tumors. This could result in fewer side effects."

In animal studies, halofuginone has been found to inhibit collagen production and angiogenesis, even if applied directly to tumors rather than given internally," said Dr. Krown. "With this trial, we are applying halofuginone to skin lesions of Kaposi's sarcoma to see if this treatment approach is effective and safe."

In this trial, people with Kaposi's sarcoma will have some of their skin tumors treated with an ointment containing halofuginone, while other tumors will be treated with an ointment that does not contain the drug. Several of the tumors will be biopsied to see if the halofuginone ointment affects tumors differently than the non-halofuginone ointment. After 12 weeks, if the halofuginone-treated tumors are improved or do not get worse, all of the skin tumors may be treated for another 12 weeks with halofuginone ointment.

Who Can Join This Trial?
This trial seeks to enroll 30 men and women aged 16 and older who have Kaposi's sarcoma confined to the skin, with at least 14 skin lesions, and HIV infection. See the full list of eligibility criteria for this trial at http://cancer.gov/clinicaltrials/AMC-036.

Where Is This Trial Taking Place?
Multiple study sites in the United States are enrolling patients in the trial. See the list of study sites at http://cancer.gov/clinicaltrials/AMC-036.

Who to Contact
See the list of study contacts at http://cancer.gov/clinicaltrials/AMC-036 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential. For more information about the NCI AIDS Malignancy Program, visit http://cancer.gov/dctd/aids/.