Leukoplakia Clinical Trial
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 Oropharynx Lesions.
Verified date | March 2015 |
Source | University of Arkansas |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas |
United States,
Shafirstein G, Friedman A, Siegel E, Moreno M, Bäumler W, Fan CY, Morehead K, Vural E, Stack BC Jr, Suen JY. Using 5-aminolevulinic acid and pulsed dye laser for photodynamic treatment of oral leukoplakia. Arch Otolaryngol Head Neck Surg. 2011 Nov;137(11) — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Day 2 | Yes |
Primary | The Objective Response Rate is the Number of Participants With Significant Response (SR), Partial Response (PR) or No Response (NR). | 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. | Day 90 | No |
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