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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
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Sarcoma, Kaposi HIV Infections Drug: Tumor Necrosis Factor Phase 1

Study Design
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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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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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