AIDS-related Kaposi Sarcoma Clinical Trial
Official title:
Phase II Study of Sunitinib (SU11248) in Patients With Kaposi's Sarcoma in East Africa
Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying the side effects and how well sunitinib malate works in treating patients with Kaposi sarcoma.
PRIMARY OBJECTIVES:
I. Determine the clinical response of sunitinib malate in patients with Kaposi sarcoma (KS)
in Uganda and Kenya.
II. Compare clinical response rates in endemic versus epidemic (AIDS) KS. III. Determine the
safety and tolerability of sunitinib malate in patients with endemic or epidemic (AIDS) KS.
SECONDARY OBJECTIVES:
I Monitor the impact of sunitinib malate on underlying HIV-1 and Kaposi sarcoma-associated
herpesvirus (KSHV) viral infection (HIV-1 plasma RNA and KSHV cell-associated DNA).
II. Evaluate morphological changes in KS lesions after treatment. III. Determine the
pharmacokinetic profile of sunitinib malate in patients with KS.
IV Evaluate KSHV gene expression in endemic and epidemic KS lesions in patients in Uganda
and Kenya.
OUTLINE: This is a multicenter study. Patients are stratified according to HIV-serostatus
(endemic [HIV-seronegative] vs epidemic [HIV-seropositive/AIDS] kaposi sarcoma).
Patients receive oral sunitinib malate 50 mg once daily for 4 weeks. Treatment repeats every
6 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection periodically for correlative and
pharmacokinetic studies. Samples are analyzed for CD4 lymphocyte counts, HIV-1 plasma RNA
levels, KSHV specific antibodies, expression pattern of KSHV in vitro and in vivo,
expression of latently versus lytically expressed genes in tumor tissue, and plasma
concentrations of sunitinib malate and its active metabolite, SU12662.
After completion of study treatment, patients are followed every 6 weeks.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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