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:

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

History of Changes

Purpose

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:

MedlinePlus related topics: Cancer HIV/AIDS Kaposi's Sarcoma Soft Tissue Sarcoma

Genetic and Rare Diseases Information Center resources: Classic Kaposi Sarcoma Malignant Mesenchymal Tumor Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility


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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002262

Locations


United States, California
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859

Sponsors and Collaborators

University of California, San Francisco

More Information

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:


Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on February 27, 2015

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