A Combined Phase I/II Single Site Study to Determine the Safety and Efficacy of Photodynamic Therapy (PDT) Utilizing 5-aminolevulinic Acid (5-ALA) and PDT in the Treatment of Premalignant Oral and/or Oropharynx Lesions.
This is a combined Phase I/II non-randomized prospective study designed to determine the
safety and assess the clinical efficacy of PDT in the treatment of oral leukeplekia with
5-ALA and 585-nm PDL with 1.5 ms pulse time. In the first part of the study we determined
the maximum tolerated dose (MTD) of the PDL radiant exposure in combination with 5-ALA. In
the second phase of the study, this dose is used to treat subjects at the MTD in order to
determine the efficacy of the treatment by documenting the regression of the treated
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose
The traditional 3+3 dose escalation design was employed. Three cohorts were enrolled at 3 subjects per cohort, and treated with escalating radiant exposures of 6, 7, or 8 J/cm2. In each cohort, the number of dose-limiting toxicities (DLTs) were observed. Dose escalation rules were the same as those provided by Storer 1989.
Gal Shafirstein, PhD
University of Arkansas
United States: Food and Drug Administration
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|