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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Sarcoma, Kaposi HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Tumor Necrosis Factor

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Locations

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San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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86-989

Identifier Type: -

Identifier Source: secondary_id

066A