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Name of the Trial

Phase II Randomized Study of Topical Halofuginone Hydrobromide in Patients with HIV-Related Kaposi Sarcoma (AMC-036). See the protocol summary ³.

Principal Investigators

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

Why This Trial Is Important

Kaposi 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 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 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 sarcoma to see if this treatment approach is effective and safe.”

In this trial, people with Kaposi 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.

Contact Information

This trial is no longer accepting new patients. To locate other clinical trials for Kaposi sarcoma, search the NCI database of clinical trials ¹ 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. You can also find information at the NCI AIDS Malignancy Program ⁴ Web site.

Glossary Terms

Blood vessel formation. Tumor angiogenesis is the growth of new blood vessels that tumors need to grow. This is caused by the release of chemicals by the tumor.

The removal of cells or tissues for examination by a pathologist. The pathologist may study the tissue under a microscope or perform other tests on the cells or tissue. There are many different types of biopsy procedures. The most common types include: (1) incisional biopsy, in which only a sample of tissue is removed; (2) excisional biopsy, in which an entire lump or suspicious area is removed; and (3) needle biopsy, in which a sample of tissue or fluid is removed with a needle. When a wide needle is used, the procedure is called a core biopsy. When a thin needle is used, the procedure is called a fine-needle aspiration biopsy.

A fibrous protein found in cartilage and other connective tissue.

An area of abnormal tissue. A lesion may be benign (not cancer) or malignant (cancer).