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Oral Oncol. 2013 Sep;49(9):970-976. doi: 10.1016/j.oraloncology.2013.05.011. Epub 2013 Jul 8.

A phase I trial of aminolevulinic acid-photodynamic therapy for treatment of oral leukoplakia.

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Medical College of Wisconsin, Milwaukee, Wisconsin, United States. Electronic address:
Medical College of Wisconsin, Milwaukee, Wisconsin, United States.
Marquette University School of Dentistry, Milwaukee, Wisconsin, United States.
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States.
Robert H. Lurie Cancer Center, United States.
Robert H. Lurie Cancer Center, United States; Center for Molecular Innovation and Drug Discovery of Northwestern University, Chicago, Illinois, United States.
Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Chicago, Illinois, United States.



Photodynamic therapy with aminolevulinic acid (ALA PDT) for oral leukoplakia has shown promising effects in regression of oral leukoplakia. Although ALA has been extensively studied and is an ideal photosensitizer, the optimal light dose for treatment of oral leukoplakia has not been determined. We conducted a phase I study to determine MTD and DLT of PDT in patients treated with ALA for leukoplakia.


Patients with histologically confirmed oral leukoplakia received a single treatment of ALA PDT in cohorts with escalating doses of light (585nm). Clinical, histologic, and biologic markers were assessed.


Analysis of 11 participants is reported. No significant toxicity from ALA PDT was observed in patients who received ALA with a light dose of up to 4J/cm(2). One participant experienced transient grade 3 transaminase elevation due to ALA. One participant had a partial clinical response 3months after treatment. Biologic mucosal risk markers showed no significant associations. Determination of MTD could not be accomplished within a feasible timeframe for completion of the study.


ALA PDT could be safely administered with a light dose up to 4J/cm(2) and demonstrated activity. Larger studies are needed to fully elucidate the MTD and efficacy of ALA-PDT.


Aminolevulinic acid; Laser; Leukoplakia; Phase I; Photodynamic therapy

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