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

Stuart J. Wong, Bruce Campbell, Becky Massey, Denis P. Lynch, Ezra E.W. Cohen, Elizabeth Blair, Rebecca Selle, Julia Shklovskaya, Borko D. Jovanovic, Silvia Skripkauskas, Alexander Dew, Peter Kulesza, Vamsi Parimi, Raymond C. Bergan, Eva Szabo

Research output: Contribution to journalArticlepeer-review

23 Scopus citations


Background 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. Methods Patients with histologically confirmed oral leukoplakia received a single treatment of ALA PDT in cohorts with escalating doses of light (585 nm). Clinical, histologic, and biologic markers were assessed. Results 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 4 J/cm2. One participant experienced transient grade 3 transaminase elevation due to ALA. One participant had a partial clinical response 3 months 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. Conclusions ALA PDT could be safely administered with a light dose up to 4 J/cm2 and demonstrated activity. Larger studies are needed to fully elucidate the MTD and efficacy of ALA-PDT.

Original languageEnglish (US)
Pages (from-to)970-976
Number of pages7
JournalOral Oncology
Issue number9
StatePublished - Sep 2013
Externally publishedYes


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

ASJC Scopus subject areas

  • Oral Surgery
  • Oncology
  • Cancer Research


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