Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Clinical Solutions
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
