Phase II Study of Sunitinib (SU11248) in Patients With Kaposi's Sarcoma in East Africa
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.
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The true response rate will be estimated based on the number of responses using a binomial distribution. The confidence intervals for them can be estimated using same distribution. Chi-square test or Fisher's exact test will be used to examine the difference of response rate between the two cohorts and log-rank test for the difference of survival outcomes.
Up to 11 months
Case Western Reserve University
United States: Food and Drug Administration
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