Phase 2
N=9
Treatment of Oral Premalignant Lesions With 5-ALA PDT
Leukoplakia · Erythroplakia
Bottom Line
View on ClinicalTrials.gov: NCT00571974 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Maximum Tolerated Dose — 8 J/cm2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PDL-585, ScleroPLUS laser (Device); 5-Aminolevulinic Acid (Levulan KerastickTM) (Drug); Fluorescence Diagnosis Imaging (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose |
8 | — |
| PRIMARY The Objective Response Rate is the Number of Participants With Significant Response (SR), Partial Response (PR) or No Response (NR). |
7; 9; 1 | 0.0001 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00571974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.