title: A phase I trial of aminolevulinic acid-photodynamic therapy for treatment of oral leukoplakia.
abstract: 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 (585nm). 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 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Medical College of Wisconsin, Milwaukee, Wisconsin, United States. Electronic address: swong@mcw.edu.
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Wong
authors.affiliation: Medical College of Wisconsin, Milwaukee, Wisconsin, United States.
authors.forename: Bruce
authors.initials: B
authors.lastname: Campbell
authors.affiliation: Medical College of Wisconsin, Milwaukee, Wisconsin, United States.
authors.forename: Becky
authors.initials: B
authors.lastname: Massey
authors.affiliation: Marquette University School of Dentistry, Milwaukee, Wisconsin, United States.
authors.forename: Denis P
authors.initials: DP
authors.lastname: Lynch
authors.affiliation: University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States.
authors.forename: Ezra E W
authors.initials: EEW
authors.lastname: Cohen
authors.affiliation: University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Blair
authors.affiliation: Medical College of Wisconsin, Milwaukee, Wisconsin, United States.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Selle
authors.affiliation: Robert H. Lurie Cancer Center, United States.
authors.forename: Julia
authors.initials: J
authors.lastname: Shklovskaya
authors.affiliation: Robert H. Lurie Cancer Center, United States.
authors.forename: Borko D
authors.initials: BD
authors.lastname: Jovanovic
authors.affiliation: Robert H. Lurie Cancer Center, United States.
authors.forename: Silvia
authors.initials: S
authors.lastname: Skripkauskas
authors.affiliation: Robert H. Lurie Cancer Center, United States.
authors.forename: Alexander
authors.initials: A
authors.lastname: Dew
authors.affiliation: Robert H. Lurie Cancer Center, United States.
authors.forename: Peter
authors.initials: P
authors.lastname: Kulesza
authors.affiliation: Robert H. Lurie Cancer Center, United States.
authors.forename: Vamsi
authors.initials: V
authors.lastname: Parimi
authors.affiliation: Robert H. Lurie Cancer Center, United States; Center for Molecular Innovation and Drug Discovery of Northwestern University, Chicago, Illinois, United States.
authors.forename: Raymond C
authors.initials: RC
authors.lastname: Bergan
authors.affiliation: Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Chicago, Illinois, United States.
authors.forename: Eva
authors.initials: E
authors.lastname: Szabo
mesh_terms: D000622:Aminolevulinic Acid / Q000627:therapeutic use*; D006801:Humans; D007972:Leukoplakia, Oral / Q000188:drug therapy*; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use*
chemical_list: D017319:Photosensitizing Agents; D000622:Aminolevulinic Acid
keywords: Aminolevulinic acid; Laser; Leukoplakia; Phase I; Photodynamic therapy