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.