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 Bergan, Eva Szabo

Research output: Contribution to journalArticle

13 Citations (Scopus)

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 (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
Volume49
Issue number9
DOIs
StatePublished - Sep 2013
Externally publishedYes

Fingerprint

Oral Leukoplakia
Aminolevulinic Acid
Photochemotherapy
Light
Therapeutics
Biomarkers
Leukoplakia
Photosensitizing Agents
Transaminases
1-phenyl-3,3-dimethyltriazene

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Oral Surgery
  • Cancer Research

Cite this

Wong, S. J., Campbell, B., Massey, B., Lynch, D. P., Cohen, E. E. W., Blair, E., ... Szabo, E. (2013). A phase i trial of aminolevulinic acid-photodynamic therapy for treatment of oral leukoplakia. Oral Oncology, 49(9), 970-976. https://doi.org/10.1016/j.oraloncology.2013.05.011

A phase i trial of aminolevulinic acid-photodynamic therapy for treatment of oral leukoplakia. / Wong, Stuart J.; Campbell, Bruce; Massey, Becky; Lynch, Denis P.; Cohen, Ezra E W; Blair, Elizabeth; Selle, Rebecca; Shklovskaya, Julia; Jovanovic, Borko D.; Skripkauskas, Silvia; Dew, Alexander; Kulesza, Peter; Parimi, Vamsi; Bergan, Raymond; Szabo, Eva.

In: Oral Oncology, Vol. 49, No. 9, 09.2013, p. 970-976.

Research output: Contribution to journalArticle

Wong, SJ, Campbell, B, Massey, B, Lynch, DP, Cohen, EEW, Blair, E, Selle, R, Shklovskaya, J, Jovanovic, BD, Skripkauskas, S, Dew, A, Kulesza, P, Parimi, V, Bergan, R & Szabo, E 2013, 'A phase i trial of aminolevulinic acid-photodynamic therapy for treatment of oral leukoplakia', Oral Oncology, vol. 49, no. 9, pp. 970-976. https://doi.org/10.1016/j.oraloncology.2013.05.011
Wong, Stuart J. ; Campbell, Bruce ; Massey, Becky ; Lynch, Denis P. ; Cohen, Ezra E W ; Blair, Elizabeth ; Selle, Rebecca ; Shklovskaya, Julia ; Jovanovic, Borko D. ; Skripkauskas, Silvia ; Dew, Alexander ; Kulesza, Peter ; Parimi, Vamsi ; Bergan, Raymond ; Szabo, Eva. / A phase i trial of aminolevulinic acid-photodynamic therapy for treatment of oral leukoplakia. In: Oral Oncology. 2013 ; Vol. 49, No. 9. pp. 970-976.
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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 (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.",
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AU - Cohen, Ezra E W

AU - Blair, Elizabeth

AU - Selle, Rebecca

AU - Shklovskaya, Julia

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AU - Skripkauskas, Silvia

AU - Dew, Alexander

AU - Kulesza, Peter

AU - Parimi, Vamsi

AU - Bergan, Raymond

AU - Szabo, Eva

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N2 - 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.

AB - 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.

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