Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma

Phase 2

Completed

Brief Summary: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with HIV-related Kaposi's sarcoma.

Detailed Description: OBJECTIVES:

Primary

* Determine clinical response in patients with HIV-related Kaposi's sarcoma treated with imatinib mesylate.

Secondary

* Determine the inhibition of platelet-derived growth factor receptors, as determined by immunohistochemistry, in patients treated with this drug.

* Determine cytokine profiles before and after treatment with this drug in these patients.

* Determine the pharmacokinetic profile of this drug and antiretrovirals in these patients.

* Determine mechanisms of primary and secondary resistance to this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral imatinib mesylate once daily. Treatment continues for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Imatinib mesylate	imatinib mesylate	Imatinib mesylate (Gleevec) taken 400 mg orally once a day for up to 6 months

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Who Achieve a Clinical Response	20-24 weeks	Clinical response = Complete Response (absence of residual disease) or Partial Response defined as no new lesions (skin or oral), or no new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions); AND 50% or greater decrease in the number of lesions lasting for \>4 weeks; OR Complete flattening of at least 50% of all previously raised lesions OR A 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions

Secondary Outcome Measures

Name	Time	Method
Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry	12 months
Mechanisms of Primary and Secondary Resistance to Imatinib Therapy	12 months	Mutations in the juxtamembrane or kinase membrane of the c-kit or PDGF receptors at baseline or time of progression
Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus	12 months
Cytokine Profiles Before and After Imatinib Therapy	12 months
Pharmacokinetic Profile of Imatinib and Antiretrovirals	12 months

Locations (15): Moores UCSD Cancer Center
🇺🇸
La Jolla, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
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Los Angeles, California, United States
Desert Regional Medical Center Comprehensive Cancer Center
🇺🇸
Palm Springs, California, United States
UCSF Comprehensive Cancer Center
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San Francisco, California, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸
Saint Louis, Missouri, United States
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Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States