Treatment of Oral Premalignant Lesions With 5-ALA PDT

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Treatments: Aminolevulinic Acid

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