EMD 121974 in Treating Patients With HIV-Related Kaposi's Sarcoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically proven Kaposi's sarcoma
• •Systemic chemotherapy not required
• •Minimum of 2 lesions amenable to biopsy
• •Measurable or evaluable disease HIV positive
• •PATIENT CHARACTERISTICS:
• •Age: 18 and over
• •Performance status: Karnofsky 70-100%
• •Life expectancy: At least 3 months
• •Hemoglobin at least 8.0 g/dL
• •Absolute neutrophil count at least 750/mm3
• •Platelet count at least 75,000/mm3
• •PT/PTT normal Bilirubin normal (bilirubin no greater than 3.5 mg/dL if secondary to indinavir therapy, provided direct bilirubin no greater than upper limit of normal (ULN))
• •AST (SGOT) no greater than 2.5 times ULN
• •Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min
• •No prior ischemic coronary artery disease including prior myocardial infarction
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 2 months after study
• •No concurrent active infection (nonsystemic infection, e.g., herpes simplex, oral thrush, or warts, allowed)
• •No gastric or duodenal ulcer within past 6 weeks unless healed
• •PRIOR CONCURRENT THERAPY:
• •At least 2 weeks since prior antineoplastic biologic therapy and recovered
• •At least 3 weeks since prior myeloid growth factor
• •Growth factors and transfusion allowed if dose requirement is stable for 4 weeks prior to therapy
• •At least 2 weeks since prior chemotherapy (6 weeks since prior nitrosourea or mitomycin) and recovered
• •Concurrent hydroxyurea as antiretroviral therapy allowed if dose stable for 4 weeks prior to study
• •No concurrent systemic cytotoxic chemotherapy
• •Recovered from prior endocrine therapy
• •At least 2 weeks since prior radiotherapy and recovered
• •No concurrent radiotherapy
• •At least 3 weeks since major surgery or 10 days since minor surgery and recovered
• •At least 4 weeks since prior experimental therapy for Kaposi's sarcoma and recovered
• •At least 2 weeks since prior local therapy to any indicator lesion
• •No concurrent investigational drugs (except antiretroviral therapy)
• •At least 2 weeks since prior acute treatment for infection or other serious medical illness
• •Antiretroviral therapy must be stable for 4 weeks prior to study