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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
400 mg orally once a day for up to 6 months.
Moores UCSD Cancer Center
La Jolla, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Proportion of Patients Who Achieve a Clinical Response
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
Time frame: 20-24 weeks
Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry
Time frame: 12 months
Cytokine Profiles Before and After Imatinib Therapy
Time frame: 12 months
Pharmacokinetic Profile of Imatinib and Antiretrovirals
Time frame: 12 months
Mechanisms of Primary and Secondary Resistance to Imatinib Therapy
Mutations in the juxtamembrane or kinase membrane of the c-kit or PDGF receptors at baseline or time of progression
Time frame: 12 months
Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus
Time frame: 12 months
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