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

Completed · Phase 1

Conditions studied: Sarcoma, Kaposi, HIV Infections

In brief

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.

Key facts

Study ID: NCT00002262
Run by: University of California, San Francisco
Last updated by the study team: 2005-06-24

Who can join

Age: 18 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Patients must have:
Biopsy-proven Kaposi's sarcoma (KS) with multiple cutaneous lesions.
Minimum life expectancy of 3 months.

You may not qualify if…

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.

Where it is running

San Francisco AIDS Clinic / San Francisco Gen Hosp — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.