Treatment of Oral Premalignant Lesions With 5-ALA PDT

University of Arkansas

Status and phase: Completed; Phase 2; Phase 1

Conditions: Leukoplakia; Erythroplakia

Treatments: Procedure: Fluorescence Diagnosis Imaging; Device: PDL-585, ScleroPLUS laser; Drug: 5-Aminolevulinic Acid (Levulan KerastickTM)

Study type: Interventional

Funder types: Other

Identifiers

NCT00571974

51439

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least one grossly visible premalignant lesion (i.e. leukoplakia or erythroplakia) in the oral cavity or oropharynx, with a confirmed diagnosis of leukoplakia with or without dysplasia,measuring ≥ 10 mm in diameter.
• Informed of alternative treatment methods including watchful waiting, laser ablation, or surgical resection.
• Eligible for long-term follow-up for at least one year and be able to tolerate biopsies.
• Subject has signed an informed consent.
• Subject is between the ages of 18 - 80 years of age.
• Male or Female
• Zubrod performance status of 0 or 1 at screening. See Appendix A

Exclusion criteria

• Known sensitivity to porphyrins or photoactive medications - See Appendix B
• Invasive carcinoma of the lesion as demonstrated by biopsy.
• Subjects with inherited or acquired blood clotting defects
• Women who are breast feeding, have a positive (+) urine pregnancy test, or refuse to use 2 effective means of contraception during drug exposure and up to 48 hours after.
• Subjects with porphyria
• Life expectancy less than 12 months
• Inability or unwillingness of subject to give written informed consent

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Phase 1 light dose escalation

Experimental group

Description:

During Phase I, to determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion. The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD). Procedure: Fluorescence Diagnosis Imaging Interventions: Application of 5-ALA to lesion followed by activation with high power 585 nm pulsed dye laser (PDL-585, ScleroPLUS laser) at 6, 7 and 8 J/cm2.

Treatment:

Device: PDL-585, ScleroPLUS laser

Procedure: Fluorescence Diagnosis Imaging

Drug: 5-Aminolevulinic Acid (Levulan KerastickTM)

Phase 2 - Treatment efficacy of PDT

Experimental group

Description:

Procedure: Fluorescence Diagnosis Imaging Interventions: Application of 5-ALA to lesion followed by activation with high power 585 nm pulsed dye laser (PDL-585, ScleroPLUS laser) at 8 J/cm2.

Treatment:

Device: PDL-585, ScleroPLUS laser

Procedure: Fluorescence Diagnosis Imaging

Drug: 5-Aminolevulinic Acid (Levulan KerastickTM)