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.
18 Years
80 Years
Both
Leukoplakia, Erythroplakia
Trial Information
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
lesions.
Inclusion Criteria:
- At least one grossly visible premalignant lesion (i.e. leukoplakia or erythroplakia)
in the oral cavity or oropharynx, with a confirmed diagnosis of leukoplakia with or
without dysplasia,measuring ≥ 10 mm in diameter.
- Informed of alternative treatment methods including watchful waiting, laser ablation,
or surgical resection.
- Eligible for long-term follow-up for at least one year and be able to tolerate
biopsies.
- Subject has signed an informed consent.
- Subject is between the ages of 18 - 80 years of age.
- Male or Female
- Zubrod performance status of 0 or 1 at screening. See Appendix A
Exclusion Criteria:
- Known sensitivity to porphyrins or photoactive medications - See Appendix B
- Invasive carcinoma of the lesion as demonstrated by biopsy.
- Subjects with inherited or acquired blood clotting defects
- Women who are breast feeding, have a positive (+) urine pregnancy test, or refuse to
use 2 effective means of contraception during drug exposure and up to 48 hours after.
- Subjects with porphyria
- Life expectancy less than 12 months
- Inability or unwillingness of subject to give written informed consent
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose
Outcome Description:
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.
Outcome Time Frame:
Day 2
Safety Issue:
Yes
Principal Investigator
Gal Shafirstein, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Arkansas
Authority:
United States: Food and Drug Administration
Study ID:
51439
NCT ID:
NCT00571974
Start Date:
January 2007
Completion Date:
January 2012
Related Keywords:
- Leukoplakia
- Erythroplakia
- Erythroplasia
- Leukoplakia
- Precancerous Conditions
Name | Location |
|---|---|
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
