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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

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

Details

• Lead Sponsor: University of California, San Francisco

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.