Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00002167
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002167
Study Brief:
Protocol Section:
NCT00002167