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

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tumor Necrosis Factor
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Skin Neoplasms, Tumor Necrosis Factor, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • San Francisco AIDS Clinic / San Francisco Gen Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00002262
Brief Title
A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
Official Title
A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 1988
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Skin Neoplasms, Tumor Necrosis Factor, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tumor Necrosis Factor

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
San Francisco AIDS Clinic / San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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