Topical Treatment for HIV-Related Kaposi Sarcoma
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.
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 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 Web site.
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