Imatinib Mesylate in Treating 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.

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