A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma

A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma

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.

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.