A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
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ClinicalTrials.gov Identifier: NCT00002262 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections | Drug: Tumor Necrosis Factor | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 |

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002262
United States, California | |
San Francisco AIDS Clinic / San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 |
ClinicalTrials.gov Identifier: | NCT00002262 History of Changes |
Other Study ID Numbers: |
066A 86-989 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | December 1988 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Skin Neoplasms Tumor Necrosis Factor Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
HIV Infections Sarcoma Necrosis Sarcoma, Kaposi Skin Neoplasms Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Pathologic Processes Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue Neoplasms by Site Skin Diseases |