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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00521092 |
RATIONALE: 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.
PURPOSE: This phase II trial is studying the side effects and how well sunitinib malate works in treating patients with Kaposi sarcoma.
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Drug: sunitinib malate Procedure: laboratory biomarker analysis Procedure: pharmacological study |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Sunitinib (SU11248) in Patients With Kaposi's Sarcoma in East Africa |
Estimated Enrollment: | 31 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Documented HIV-serostatus
PATIENT CHARACTERISTICS:
Inclusion criteria:
No acute infections
Exclusion criteria:
Uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Concurrent antiretroviral therapy required for HIV-seropositive patients
Patient must be on a stable regimen 8 weeks prior to study enrollment
Study ID Numbers: | CDR0000561751, CASE-1706, AMC-049 |
Study First Received: | August 24, 2007 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00521092 |
Health Authority: | Unspecified |
AIDS-related Kaposi sarcoma classic Kaposi sarcoma Treatment Experienced |
Virus Diseases Neoplasms, Connective and Soft Tissue Kaposi sarcoma Sunitinib Malignant mesenchymal tumor |
Sarcoma, Kaposi Sarcoma DNA Virus Infections Soft tissue sarcomas Herpesviridae Infections |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Therapeutic Uses Physiological Effects of Drugs |
Neoplasms, Vascular Tissue Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |