A Phase I Trial of EMD 121974 in 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