Spots Global Cancer Trial Database for Treatment of Oral Premalignant Lesions With 5-ALA PDT

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Trial Identification

Brief Title: Treatment of Oral Premalignant Lesions With 5-ALA PDT

Official Title: A Combined Phase I/II Single Site Study to Determine the Safety and Efficacy of Photodynamic Therapy (PDT) Utilizing 5-aminolevulinic Acid (5-ALA) and PDT in the Treatment of Premalignant Oral and/or Oropharynx Lesions.

Study ID: NCT00571974

Conditions

Leukoplakia

Erythroplakia

Interventions

PDL-585, ScleroPLUS laser

5-Aminolevulinic Acid (Levulan KerastickTM)

Fluorescence Diagnosis Imaging

Study Description

Brief Summary: Oral leukoplakia within the mouth is a visible white patch which can develop into cancer if not treated. There is no good treatment for these lesions, apart from surgery which is associated with significant side effects and physical deformation of the treated area. The investigators hypothesized that photodynamic therapy can be used safely and effectively to induce significant regression of oral leukoplakia.

Detailed Description: This is a combined Phase I/II non-randomized prospective study designed to determine the safety and assess the clinical efficacy of PDT in the treatment of oral leukeplekia with 5-ALA and 585-nm PDL with 1.5 ms pulse time. In the first part of the study we determined the maximum tolerated dose (MTD) of the PDL radiant exposure in combination with 5-ALA. In the second phase of the study, this dose is used to treat subjects at the MTD in order to determine the efficacy of the treatment by documenting the regression of the treated lesions.