Silicon Phthalocyanine Pc4 for Photodynamic Therapy of Cutaneous T-cell Lymphoma: Single and Repeated Photoexposures
I. Determine the safety and maximum tolerated dose (MTD) that can be utilized for a single
treatment of Pc 4-PDT (silicon phthalocyanine 4 photo dynamic therapy) on subjects with
mycosis fungoides (MF)/cutaneous T-cell lymphoma (CTCL) stage IA-IIA, by evaluating an
accelerated dose escalation protocol consisting of a single exposure to PDT using
topically-applied Pc 4 and visible light at a wavelength of 675 nm, followed by assessment
of skin biopsies to analyze cellular and molecular changes induced by Pc 4-PDT. (Cohort I)
II. Determine safety and tolerability of repeated light (PDT) exposures after a single
application of Pc 4 to a MF/CTCL plaque, using topically-applied Pc 4 and visible light at a
wavelength of 675nm, followed by assessment of skin biopsies to analyze cellular and
molecular changes induced by Pc 4-PDT. (Cohort II)
III. Identification of targets for assessment of efficacy to assist in planning for a Phase
OUTLINE: This is a dose-escalation study.
Patients receive silicon phthalocyanine 4 topically and then undergo PDT.
After completion of study treatment, patients are followed up at 24 hours, 1 week, 2 weeks,
and 30 days.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the dose immediately below the dose in which 2 or more of 6 patients experience a grade 4 toxicity assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Up to 30 days
Elma Baron, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|