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

Inclusion Criteria

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.