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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002262
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma, Kaposi, HIV Infections

Keywords

Skin Neoplasms, Tumor Necrosis Factor, Acquired Immunodeficiency Syndrome

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.

Interventions

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026