Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.
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To determine the objective tumor response and remission rate of AIDS-related Kaposi's sarcomas (KS) following a single dose of tin ethyl etiopurpurin (SnET2) followed by photodynamic therapy (PDT). To determine the systemic and local toxicity, and morbidity safety profile of SnET2-PDT.
Condition or disease
Sarcoma, KaposiHIV Infections
Drug: Tin ethyl etiopurpurin
All patients receive a single dose of SnET2 and are randomized to receive either PDT light treatment or no light treatment (control group). Patients are assessed prior to and at 4, 12 and 24 weeks following treatment, and are followed for 7 months.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have:
Documentation of at least one biopsy-confirmed KS lesion.
A minimum of 4 and no more than 36 KS lesions.
All eligible lesions must be bidimensionally measurable, treatable by surface (non-contact) light illumination, and <= 40 mm in diameter of the longest bidimensional axis.
ACTG disease state T(0) L(0) or (1) S(0) or (1).
Life expectancy greater than 6 months.
Patients with the following symptoms or conditions are excluded:
Active opportunistic infection or condition except thrush or herpes simplex virus infections.
Advanced KS tumor stages including the presence of tumor associated edema or ulceration, extensive oral KS, or KS in other non-nodal viscera.
Cardiovascular dysfunction - Presence of significant coronary artery disease requiring current treatment or myocardial infarction.
Known disorder of lipoprotein metabolism or clearance.
Patients with the following prior conditions are excluded:
History of allergic or hypersensitivity reactions to light, egg proteins or egg yolks, history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
Excluded within 7 days of therapy:
Excluded within 3 months of therapy:
Excluded within 6 months of therapy:
Intralesional chemotherapy within the past 12 weeks.
Systemic chemotherapy or investigational drugs within the past 4 weeks.
Immune System Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
DNA Virus Infections
Neoplasms, Vascular Tissue