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.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	University of California, San Francisco
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002262

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 I

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison
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: AIDS Cancer Kaposi's Sarcoma Skin Cancer Soft Tissue Sarcoma

Drug Information available for: Tumor Necrosis Factors

U.S. FDA Resources

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

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

Study ID Numbers:	066A, 86-989
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002262 History of Changes
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

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Skin Diseases
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Skin Neoplasms
Immunologic Deficiency Syndromes
Kaposi Sarcoma
Herpesviridae Infections
Virus Diseases

Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Necrosis
HIV Infections
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:

Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Infection
Neoplasms, Connective and Soft Tissue
Necrosis
Pathologic Processes
Neoplasms by Site
Neoplasms, Vascular Tissue
Retroviridae Infections
RNA Virus Infections
Neoplasms by Histologic Type
Immune System Diseases
Skin Diseases

Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Skin Neoplasms
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Neoplasms
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Sarcoma
DNA Virus Infections

ClinicalTrials.gov processed this record on September 01, 2009