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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIDS Malignancy Consortium
• Collaborators: National Cancer Institute (NCI); The Emmes Company, LLC; The EMMES Corporation
• Treatments: Imatinib Mesylate

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