Sunitinib Malate in Treating HIV-Positive Patients With Cancer Undergoing Highly Active Antiretroviral Therapy



Status:Archived
Conditions:Cancer, Cancer, Brain Cancer, Blood Cancer, Lymphoma, Hematology, Kidney Cancer, Leukemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:August 2009

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A Phase 1/Pharmacokinetic Study of Sunitinib in Patients With Cancer Who Also Have HIV and Are on HAART Therapy


RATIONALE: Sunitinib malate may stop the growth of cancer cells by blocking blood flow to
the cancer and by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects of sunitinib malate in treating
HIV-positive patients with cancer undergoing highly active antiretroviral therapy.


OBJECTIVES:

Primary

- To determine the safety of sunitinib malate in HIV-positive patients with cancer
undergoing highly active antiretroviral therapy (HAART) containing protease inhibitors
and/or non-nucleoside reverse transcriptase inhibitors.

- To investigate the pharmacological interactions of sunitinib malate.

Secondary

- To evaluate the efficacy of sunitinib malate in treating patients with
non-AIDS-defining cancers.

- To detect alterations in antiretroviral drug pharmacokinetics due to sunitinib malate.

- To detect alterations in immune parameters, including total leukocyte count, CD4 count,
and viral load, during treatment with sunitinib malate.

- To correlate variations in genes involved in sunitinib malate absorption, metabolism,
and elimination (e.g., CYP3A4, CYP3A5, ABCB1, and ABCG2) with drug pharmacokinetics.

- To explore the potential for pharmacological interactions between sunitinib and newer
antiretroviral agents such as integrase and CCR5 inhibitors.

OUTLINE: This is a multicenter study. Patients are stratified according to type of highly
active antiretroviral therapy (non-nucleoside reverse transcriptase inhibitor-based therapy
vs non-ritonavir protease inhibitor [PI]-based therapy vs ritonavir PI-based therapy).

Patients receive oral sunitinib malate once daily for 4 weeks. Courses repeat every 6 weeks
in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for pharmacokinetic studies by liquid
chromatography-tandem mass spectrometry (LC-MS/MS).

After completion of study therapy, patients are followed for at least 1 month.


We found this trial at
9
sites
10833 Le Conte Ave
Los Angeles, California 90095
(310) 825-4321
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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4000 Reservoir Road NW, Suite 120
Washington, Washington DC 20007
(202) 687-0100
Georgetown Univ Med Ctr Georgetown University Medical Center is committed to excellence in research, education...
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Washington, DC
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136 Mountainview Blvd
Basking Ridge, New Jersey 7920
(908) 542-3000
Memorial Sloan-Kettering Cancer Center - Basking Ridge At Memorial Sloan Kettering Basking Ridge, we offer...
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Philadelphia, Pennsylvania 19106
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Philadelphia, PA
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Seattle, WA
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660 S Euclid Ave
St. Louis, Missouri 63110
(800) 600-3606
Siteman Cancer Center The Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University...
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St. Louis, MO
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Washington, DC
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