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.