EMD 121974 in Treating Patients With HIV-Related Kaposi's Sarcoma
Sarcoma
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma
Eligibility 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
Sites / Locations
- University of California San Diego Cancer Center
- UCSF Cancer Center and Cancer Research Institute
- Vanderbilt Cancer Center
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive EMD 121974 IV twice a week for four weeks. Courses repeat every 4 weeks in the absence of disease progression. Cohorts of 3-6 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities.