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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002262 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
Official Title ^ICMJE	A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
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.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Dose Comparison
Condition ^ICMJE	Sarcoma, Kaposi HIV Infections
Intervention ^ICMJE	Drug: Tumor Necrosis Factor
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Male
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002262
Responsible Party
Study ID Numbers ^ICMJE	066A, 86-989
Study Sponsor ^ICMJE	University of California, San Francisco
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	December 1988
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP