Pre-cancerous lesions within the mouth are visible white patches which can develop into
cancer if not treated. Medical options including waiting and seeing, treatment, and
surgery. Surgery is the most effective way of destruction of cancerous lesions; however, it
can result in scarring or deformation of the tongue, cheek, or gums. With surgery there is
no guarantee that all of the lesion is removed or that the surrounding areas will not be
cancerous or that the lesion will not return. These areas can be too small for detection by
a surgeon. This study is to determine the effectiveness of a new treatment for
pre-cancerous lesions of the oral cavity by photodynamic therapy (PDT). PDT involves a drug
that is attached to the precancerous and cancerous areas and activated with a laser light to
destroy unhealthy tissue while sparing healthy adjacent tissue. The PDT procedure is
completed in 60 minutes, give or take 30 minutes, depending on the size of the lesions.
The investigator hypothesizes that the PDT using 5-ALA and PDL-585 can be used safely and
effectively to induce significant regression of oral precancerous lesions.
- 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
- 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
- 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