Clinical Trial: Treatment of Oral Premalignant Lesions With 5-ALA PDT

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief Summary:

Oral leukoplakia within the mouth is a visible white patch which can develop into cancer if not treated. There is no good treatment for these lesions, apart from surgery which is associated with significant side effects and physical deformation of the treated area.

The investigators hypothesized that photodynamic therapy can be used safely and effectively to induce significant regression of oral leukoplakia.


Detailed Summary: 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 lesions.
Sponsor: University of Arkansas

Current Primary Outcome:

  • Maximum Tolerated Dose [ Time Frame: Day 2 ]
    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.
  • The Objective Response Rate is the Number of Participants With Significant Response (SR), Partial Response (PR) or No Response (NR). [ Time Frame: Day 90 ]
    The response rate was quantified by examination by an experienced head and neck surgeon and classified as follows: significant response (SR) was one where the lesion had greater than 75% resolution, partial response (PR) was one in which the lesion was reduced in size by at least 25%, and no response (NR) was one where the lesion was reduced by less than 25% in size.


Original Primary Outcome:

  • Maximum Tolerated Dose [ Time Frame: duration of study ]
  • Objective Response Rate [ Time Frame: Day 90 ]


Current Secondary Outcome:

Original Secondary Outcome: Biomarkers [ Time Frame: at biopsies before and after treatment ]

Information By: University of Arkansas

Dates:
Date Received: December 5, 2007
Date Started: January 2007
Date Completion:
Last Updated: March 4, 2015
Last Verified: March 2015