A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
This study has been completed.
Sponsor:
University of California, San Francisco
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002262
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1988
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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.
Condition | Intervention | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections |
Drug: Tumor Necrosis Factor |
Phase 1 |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
Official Title: | A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
![](https://webarchive.library.unt.edu/web/20130225141707im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.
![](https://webarchive.library.unt.edu/web/20130225141707im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
![](https://webarchive.library.unt.edu/web/20130225141707im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
ClinicalTrials.gov Identifier: | NCT00002262 History of Changes |
Other Study ID Numbers: | 066A, 86-989 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Skin Neoplasms Tumor Necrosis Factor Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Necrosis Sarcoma, Kaposi Skin Neoplasms Sarcoma Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Pathologic Processes Herpesviridae Infections DNA Virus Infections Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue Neoplasms by Site Skin Diseases |
ClinicalTrials.gov processed this record on February 21, 2013