Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.

Inclusion Criteria

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.

Exclusion Criteria

Co-existing Condition:

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.
• Hematopoietic dysfunction.
• Coagulation dysfunction.
• Hepatic dysfunction.
• Renal dysfunction.
• Cardiovascular dysfunction - Presence of significant coronary artery disease requiring current treatment or myocardial infarction.
• Pulmonary dysfunction.
• Sepsis.
• 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:

• Hematopoietic dysfunction.
• Coagulation dysfunction.
• Hepatic dysfunction.
• Renal dysfunction.

Excluded within 3 months of therapy:

• Pulmonary dysfunction.

Excluded within 6 months of therapy:

• Myocardial infarction.

Prior Medication:

Excluded:

• Intralesional chemotherapy within the past 12 weeks.
• Systemic chemotherapy or investigational drugs within the past 4 weeks.

Prior Treatment:

Excluded within 3 months prior to therapy:

• Local cryotherapy or surgery to study lesions.
• Systemic or topical photodynamic therapy agents.