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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:

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
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:
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 June 17, 2013