Sarcoma, Kaposi, HIV Infections
Conditions
Keywords
Skin Neoplasms, Tumor Necrosis Factor, Acquired Immunodeficiency Syndrome
Brief summary
To evaluate tolerance, toxicity, and preliminary evidence of antitumor efficacy of intralesionally administered tumor necrosis factor (TNF) and to define a maximum tolerated dose (MTD) for single intralesional injections. In addition, to assess the effects of TNF injections on Kaposi's sarcoma (KS) lesions as measured by P-32 magnetic resonance spectroscopy.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Patients must have: * Biopsy-proven Kaposi's sarcoma (KS) with multiple cutaneous lesions. * Minimum life expectancy of 3 months.
Exclusion criteria
Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Clinically significant cardiac disease. * Known hemorrhagic diathesis or active bleeding disorder. * Clinically apparent vascular disease. * Known lipoprotein disorders. * History of seizure disorder or central nervous system (CNS) metastasis. * Additional malignancy. Concurrent Medication: Excluded: * Cardiac agents. * Anticoagulants. * Thrombolytic agents. * Nonsteroidal anti-inflammatory drugs. * Corticosteroids. * Aspirin. * Vasodilators. Patients with the following are excluded: * Additional malignancies or other conditions listed in Patient Exclusion Co-Existing Conditions. Prior Treatment: Excluded within 4 weeks of study entry: * Chemotherapy. * Radiotherapy. * Immunotherapy.
Countries
United States