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A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT00002262
Collaborator
(none)
1
Location

Study Details

Study Description

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
  • Drug: Tumor Necrosis Factor
 Phase 1

Study Design

Study Type:
Interventional
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    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

    Locations

    Site City State Country Postal Code
    1 San Francisco AIDS Clinic / San Francisco Gen Hosp San Francisco California United States 941102859

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002262
    Other Study ID Numbers:
    • 066A
    • 86-989
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Dec 1, 1988
    Keywords provided by , ,
    Skin Neoplasms
    Tumor Necrosis Factor
    Acquired Immunodeficiency Syndrome
    Additional relevant MeSH terms:
    Sarcoma, Kaposi
    Sarcoma
    Necrosis

    Study Results

    No Results Posted as of Jun 24, 2005