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


Phase 1
18 Years
70 Years
Not Enrolling
Male
Sarcoma, Kaposi, HIV Infections

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Trial Information

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

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

066A

NCT ID:

NCT00002262

Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Skin Neoplasms
  • Tumor Necrosis Factor
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Necrosis
  • Sarcoma, Kaposi
  • Skin Neoplasms
  • Sarcoma

Name

Location

San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, California  941102859