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

• Status: Terminated
• Trial end date: 2001-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of EMD 121974 in treating patients who have HIV-related Kaposi's sarcoma. EMD 121974 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

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