Sarcoma Clinical Trial
Official title:
A Phase II Trial Of Imatinib Mesylate (Gleevec) In Patients With HIV Related Kaposi's Sarcoma
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.
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