Treatment of Oral Premalignant Lesions With 5-ALA PDT

NCT ID: NCT00571974

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2012-01-31

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.

Conditions

Leukoplakia; Erythroplakia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 light dose escalation

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.

Group Type: EXPERIMENTAL

PDL-585, ScleroPLUS laser

Intervention Type: DEVICE

PDT Treatment; emits light with 585 nm wavelength in pulses of 1.5 milliseconds in sections of 5 mm diameter to target the lesion and surrounding tissue

5-Aminolevulinic Acid (Levulan KerastickTM)

Intervention Type: DRUG

Topically administered; incubation time 60-180 minutes; single dose (345 mg of active 5-ALA in 1.5 ml solution); soaked onto white gauze and applied to lesion, covered with sterile Xeroform gauze

Fluorescence Diagnosis Imaging

Intervention Type: PROCEDURE

FD Image taken prior to PDL-585 usage

Phase 2 - Treatment efficacy of PDT

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.

Group Type: EXPERIMENTAL

PDL-585, ScleroPLUS laser

Intervention Type: DEVICE

PDT Treatment; emits light with 585 nm wavelength in pulses of 1.5 milliseconds in sections of 5 mm diameter to target the lesion and surrounding tissue

5-Aminolevulinic Acid (Levulan KerastickTM)

Intervention Type: DRUG

Topically administered; incubation time 60-180 minutes; single dose (345 mg of active 5-ALA in 1.5 ml solution); soaked onto white gauze and applied to lesion, covered with sterile Xeroform gauze

Fluorescence Diagnosis Imaging

Intervention Type: PROCEDURE

FD Image taken prior to PDL-585 usage

Interventions

PDL-585, ScleroPLUS laser

PDT Treatment; emits light with 585 nm wavelength in pulses of 1.5 milliseconds in sections of 5 mm diameter to target the lesion and surrounding tissue

Intervention Type: DEVICE

5-Aminolevulinic Acid (Levulan KerastickTM)

Topically administered; incubation time 60-180 minutes; single dose (345 mg of active 5-ALA in 1.5 ml solution); soaked onto white gauze and applied to lesion, covered with sterile Xeroform gauze

Intervention Type: DRUG

Fluorescence Diagnosis Imaging

FD Image taken prior to PDL-585 usage

Intervention Type: PROCEDURE

Other Intervention Names

5-ALA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gal Shafirstein, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

References

Shafirstein G, Friedman A, Siegel E, Moreno M, Baumler W, Fan CY, Morehead K, Vural E, Stack BC Jr, Suen JY. Using 5-aminolevulinic acid and pulsed dye laser for photodynamic treatment of oral leukoplakia. Arch Otolaryngol Head Neck Surg. 2011 Nov;137(11):1117-23. doi: 10.1001/archoto.2011.178.

Reference Type: RESULT

PMID: 22106236 (View on PubMed)

Other Identifiers

51439

Identifier Type: -

Identifier Source: org_study_id