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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002262 on ClinicalTrials.gov Archive Site
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A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma

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.

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Interventional
Phase 1
Primary Purpose: Treatment
  • Sarcoma, Kaposi
  • HIV Infections
Drug: Tumor Necrosis Factor
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Male
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002262
066A, 86-989
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University of California, San Francisco
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NIH AIDS Clinical Trials Information Service
December 1988

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP