Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma, Kaposi; Sarcoma
Intervention: imatinib mesylate
Intervention description: 400 mg orally once a day for up to 6 months.
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: AIDS-related Kaposi sarcoma; recurrent Kaposi 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.
    

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