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Investigator(s):
Robert Yarchoan, M.D. Principal Investigator Phone: 301-496-8959 yarchoan@helix.nih.gov	Thomas Uldrick, M.D. Lead 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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Primary Eligibility:

• Histologically confirmed Kaposi's sarcoma (KS)
  • HIV-related or HIV-unrelated (classic) KS
• Measurable disease, as defined by one of the following:
  • At least 5 measurable cutaneous KS lesions that have not been previously treated with local therapy
  • Other measurable noncutaneous disease that permit a response to be assessed
• Patients with HIV-related KS must be receiving and willing to comply with a highly active antiretroviral therapy (HAART) regimen that either utilizes ≥ 3 drugs OR attains suppression of HIV to below the limit of detection (50 copies HIV/mL)
• HIV-related KS lesions must meet one of the following criteria:
  • Increasing during the 3 months prior to screening while the patient is receiving HAART or has unchanged suppression of HIV to below the limit of detection
  • Stable for at least 4 months while the patient is taking HAART
• No extensive, active, or symptomatic pulmonary KS
• No symptomatic visceral KS, except for that involving the oral cavity
• No KS that appears to be improving after other therapy
• Hemoglobin > 9 g/dL ,WBC > 1,000/mm³, Platelet count > 75,000/mm³, PT and PTT ≤ 120% of control, unless lupus anticoagulant present
• Bilirubin ≤ 1.5 times upper limit of normal (ULN) (for patients not receiving protease inhibitor therapy) OR total bilirubin ≤ 3.7 mg/dL with a direct bilirubin fraction ≤ 0.2 mg/dL (for patients receiving protease inhibitor therapy), AST ≤ 2.5 times ULN
• Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min
• Lipase ≤ 2 times ULN OR amylase ≤ 2 times ULN (unless documented to be of nonpancreatic origin or associated with macroamylasemia)

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Study Outline:

This is a dose-escalation, parallel group study.

• Patients are stratified according to concurrent ritonavir treatment (yes vs. no) and HIV-related Kaposi's sarcoma (KS) (yes vs. no)
• Patients receive oral sorafenib once or twice daily on Days 1 through 21
• Treatment repeats every 21 days for up to 18 courses (54 weeks) in the absence of disease progression or unacceptable toxicity
• Groups of 6 patients per stratum receive escalating doses of sorafenib until the maximum tolerated dose is determined
• After completion of study therapy, patients are followed for 3 to 6 weeks

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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.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/12/09
Updated: 7/30/09