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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.

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

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

Drug Information available for:   Tumor Necrosis Factors   

U.S. FDA Resources

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
  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


Study ID Numbers:   066A, 86-989
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002262
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
Malignant mesenchymal tumor
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Skin Neoplasms
Soft tissue sarcomas
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Kaposi sarcoma
Necrosis
HIV Infections
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:
Neoplasms
RNA Virus Infections
Neoplasms by Site
Neoplasms by Histologic Type
Pathologic Processes
Slow Virus Diseases
Immune System Diseases
Neoplasms, Vascular Tissue
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on December 03, 2008




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