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Investigator(s):
Robert Yarchoan, M.D. Principal Investigator Phone: 301-496-8959 robert.yarchoan@nih.gov	Mark N. Polizzotto, M.B.B.S., BMedSc Lead Associate Investigator Phone: 301-402-1541 mark.polizzotto@nih.gov	Thomas Uldrick, M.D. Associate Investigator Phone: 301-496-8959 uldrickts@mail.nih.gov
Referral Contact(s):
Kathy Wyvill, R.N. Research Nurse Phone: 301-496-8959 1-800-243-2732 ext. 4 (Toll Free) Fax: 301-402-7552 wyvillk@mail.nih.gov	Karen Aleman, R.N., B.S.N. Research Nurse Phone: 301-496-8959 1-800-243-2732 ext. 4 (Toll Free) Fax: 301-402-7552 alemank@mail.nih.gov

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Key Eligibility Criteria:

• Histologically confirmed Kaposi sarcoma (KS)
• Adults ≥ 18 years of age with any HIV status
• For patients with HIV-associated KS:
• Must be receiving and be adherent to an HAART regimen consistent with current clinical guidelines
• Achieved an HIV VL < 10,000 copies/mL
• Subjects with HIV-associated KS must have disease that is either progressing despite ≥ 2 months of suppressive HAART or stable despite ≥ 3 months of HAART
• No symptomatic pulmonary or visceral KS (except for non-ulcerating disease restricted to the oral cavity)
• At least five measurable KS lesions with no previous local therapy
• ECOG ≤ 2
• Able to take aspirin 81mg daily or able to take a substitute thromboprophylaxis such as low molecular weight heparin at a thromboprophylactic dose
• Adequate bone marrow and organ function
• Able to swallow capsules
• Not pregnant or breast feeding and willing to use effective birth control

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Study Outline:

Phase I/II study. Phase I completed, now accruing to Phase II.

• Screening physical examination; blood samples; and chest X-ray to determine eligibility for the study; other imaging studies may be performed if clinically indicated
• Pomalidomide capsules by mouth daily for 21 days of a 28-day cycle
• Participants will have up to six cycles of treatment, unless the lesions completely resolve sooner; if there are signs of improvement after six cycles but the lesions are not completely gone, up to another six cycles of treatment may be given
• Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/14/12
Updated: 7/12/12