Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase 1/Pharmacokinetic Study of Sunitinib in Patients With Cancer Who Also Have HIV and Are on HAART Therapy
This phase I trial studies the side effects and the best dose of sunitinib malate in treating human immunodeficiency virus (HIV)-positive patients with cancer receiving antiretroviral therapy. Sunitinib malate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PRIMARY OBJECTIVES:
I. To determine the safety and to investigate the pharmacological interactions of
administering sunitinib (sunitinib malate) in subjects with cancer who are also HIV positive
on anti-retroviral regimens containing protease inhibitors and/or non-nucleoside reverse
transcriptase inhibitors.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy of sunitinib in treating non-acquired immunodeficiency syndrome
(AIDS) defining cancers (NADCs) in these subjects.
II. To detect alterations in antiretroviral drug pharmacokinetics due to sunitinib.
III. To detect alterations in immune parameters, including total leukocyte count, cluster of
differentiation (CD) 4 and viral load, during sunitinib therapy.
IV. To correlate variations in genes involved in sunitinib absorption, metabolism, and
elimination, including cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4),
cytochrome P450, family 3, subfamily A, polypeptide 5 (CYP3A5), ATP-binding cassette,
sub-family B (MDR/TAP), member 1 (ABCB1), and breast cancer resistance protein (ABCG2), with
drug pharmacokinetics.
V. To explore the potential for pharmacological interactions between sunitinib and newer
antiretroviral agents such as integrase and chemokine (C-C motif) receptor 5
(gene/pseudogene) (CCR5) inhibitors.
OUTLINE: This is a dose-escalation study.
Patients receive sunitinib malate orally (PO) daily on days 1-28. Courses repeat every 6
weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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