Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT00521092

Sunitinib Malate in Treating East African Patients With Kaposi Sarcoma

Phase II Study of Sunitinib (SU11248) in Patients With Kaposi's Sarcoma in East Africa

Status
Withdrawn
Phase
Phase 2
Study type
Interventional
Enrollment
0 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGsunitinib malateGiven orally
PROCEDURElaboratory biomarker analysisCorrelative study
PROCEDUREpharmacological studyCorrelative study

Timeline

Start date
2009-01-01
Primary completion
2010-10-01
First posted
2007-08-27
Last updated
2014-05-05

Source: ClinicalTrials.gov record NCT00521092. Inclusion in this directory is not an endorsement.