NCT00002262

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 1988

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Sarcoma, KaposiHIV Infections

Keywords

Skin NeoplasmsTumor Necrosis FactorAcquired Immunodeficiency Syndrome

Interventions

Tumor Necrosis FactorDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • Biopsy-proven Kaposi's sarcoma (KS) with multiple cutaneous lesions.
  • Minimum life expectancy of 3 months.

You may not qualify if:

  • 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.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

MeSH Terms

Conditions

Sarcoma, KaposiHIV InfectionsSkin NeoplasmsAcquired Immunodeficiency Syndrome

Interventions

Tumor Necrosis Factor-alpha

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesMonokinesCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsTumor Necrosis FactorsBlood ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1988-12

Locations

US(1)