imatinib mesylate in treating patients with hiv-related kaposi's sarcoma

Conditions: Sarcoma

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.

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.

Eligibility criteria:
disease characteristics: * histologically confirmed kaposi's sarcoma (ks) involving at least 1 of the following areas: * skin * lymph nodes * oral cavity * gastrointestinal tract\* * lungs\* note: \*must be asymptomatic or minimally symptomatic and does not require systemic cytotoxic therapy * serological documentation of hiv infection, as evidenced by positive enzyme-linked immunosorbent assay (elisa), western blot test, or other federally approved licensed hiv test * at least 5 measurable, non-irradiated, cutaneous indicator lesions * patients must have 3 lesions at least 5 x 5 mm that are accessible for 4 mm punch biopsy patient characteristics: age * 18 and over performance status * karnofsky 60-100% life expectancy * at least 3 months hematopoietic * hemoglobin ≥ 8.0 g/dl * absolute neutrophil count ≥ 1,000/mm\^3 * platelet count ≥ 75,000/mm\^3 hepatic * ast and alt ≤ 2.5 times upper limit of normal * bilirubin normal * patients with elevated bilirubin secondary to indinavir or atazanavir allowed provided total bilirubin is \< 3.5 mg/dl and direct bilirubin is normal * no acute or known chronic liver disease (e.g., chronic active hepatitis or cirrhosis) * hepatitis c infection with minimal or no fibrosis on liver biopsy allowed renal * creatinine ≤ 1.5 mg/dl or * creatinine clearance \> 60 ml/min cardiovascular * no new york heart association class iii or iv cardiac disease * no congestive heart failure * no myocardial infarction within the past 6 months other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective barrier contraception during and for 3 months after study participation * no concurrent active opportunistic infection * no other severe and/or life-threatening medical disease * no other malignancy within the past 5 years except clinically insignificant malignancy not requiring active intervention, basal cell skin cancer, or carcinoma in situ of the cervix prior concurrent therapy: biologic therapy * more than 4 weeks since prior biologic therapy for ks * more than 2 weeks since prior granulocyte colony-stimulating factor * no concurrent biologic agents for ks chemotherapy * more than 4 weeks since prior chemotherapy for ks (6 weeks for nitrosoureas or mitomycin) * no concurrent chemotherapy for ks, including systemic cytotoxic chemotherapy endocrine therapy * no concurrent systemic corticosteroid therapy except replacement doses radiotherapy * see disease characteristics * more than 4 weeks since prior radiotherapy for ks * no concurrent radiotherapy for ks surgery * more than 2 weeks since prior major surgery other * no prior imatinib mesylate * more than 60 days since prior local therapy to any ks indicator lesion unless the lesion has progressed since treatment * more than 4 weeks since prior investigational therapy for ks * more than 4 weeks since other prior therapy for ks * more than 14 days since prior acute treatment for an infection or other serious medical illness * no concurrent warfarin * no concurrent grapefruit juice * no other concurrent therapy for ks * no other concurrent investigational drugs * concurrent antiretroviral therapy required except for patients who have exhausted all available treatment options

Keywords: aids-related kaposi sarcoma recurrent kaposi sarcoma