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

Inclusion Criteria

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.