- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002262
A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
June 23, 2005 updated by: University of California, San Francisco
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 941102859
- San Francisco AIDS Clinic / San Francisco Gen Hosp
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (ESTIMATE)
August 31, 2001
Study Record Updates
Last Update Posted (ESTIMATE)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
December 1, 1988
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 066A
- 86-989
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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