Treatment of Oral Premalignant Lesions With 5-ALA PDT

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