A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
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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.
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have:
Biopsy-proven Kaposi's sarcoma (KS) with multiple cutaneous lesions.
Minimum life expectancy of 3 months.
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.
Nonsteroidal anti-inflammatory drugs.
Patients with the following are excluded:
Additional malignancies or other conditions listed in Patient Exclusion Co-Existing Conditions.
Immunologic Deficiency Syndromes
Immune System Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
DNA Virus Infections
Neoplasms, Vascular Tissue
Neoplasms by Site