Treatment of Oral Premalignant Lesions With 5-ALA PDT - Full Text View

Sponsored by:	University of Arkansas
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00571974

Purpose

Pre-cancerous lesions within the mouth are visible white patches which can develop into cancer if not treated. Medical options including waiting and seeing, treatment, and surgery. Surgery is the most effective way of destruction of cancerous lesions; however, it can result in scarring or deformation of the tongue, cheek, or gums. With surgery there is no guarantee that all of the lesion is removed or that the surrounding areas will not be cancerous or that the lesion will not return. These areas can be too small for detection by a surgeon. This study is to determine the effectiveness of a new treatment for pre-cancerous lesions of the oral cavity by photodynamic therapy (PDT). PDT involves a drug that is attached to the precancerous and cancerous areas and activated with a laser light to destroy unhealthy tissue while sparing healthy adjacent tissue. The PDT procedure is completed in 60 minutes, give or take 30 minutes, depending on the size of the lesions.

The investigator hypothesizes that the PDT using 5-ALA and PDL-585 can be used safely and effectively to induce significant regression of oral precancerous lesions.

Condition	Intervention	Phase
Precancerous Lesions of the Oral Cavity Leukoplakia Erythroplakia	Device: PDL-585, ScleroPLUS laser Drug: 5-Aminolevulinic Acid (Levulan KerastickTM) Procedure: Fluorescence Diagnosis Imaging	Phase I Phase II

Drug Information available for: Aminolevulinic acid Aminolevulinic acid hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
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.

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Maximum tolerated dose [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
Objective Response Rate [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Biomarkers [ Time Frame: at biopsies before and after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	26
Study Start Date:	January 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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).	Device: 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 Drug: 5-Aminolevulinic Acid (Levulan KerastickTM) Topically administered; incubation time 60-180 minutes; single dose (345 mg of active 5-ALA in 1.5 ml solutioon); soaked onto white gauze and applied to lesion, covered with sterile Xeroform gauze Procedure: Fluorescence Diagnosis Imaging FD Image taken prior to PDL-585 usage
2: Experimental During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.	Device: 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 Drug: 5-Aminolevulinic Acid (Levulan KerastickTM) Topically administered; incubation time 60-180 minutes; single dose (345 mg of active 5-ALA in 1.5 ml solutioon); soaked onto white gauze and applied to lesion, covered with sterile Xeroform gauze Procedure: Fluorescence Diagnosis Imaging FD Image taken prior to PDL-585 usage

Arms

Assigned Interventions

1: Experimental

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).

Device: 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

Drug: 5-Aminolevulinic Acid (Levulan KerastickTM)

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

Procedure: Fluorescence Diagnosis Imaging

FD Image taken prior to PDL-585 usage

2: Experimental

During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.

Device: 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

Drug: 5-Aminolevulinic Acid (Levulan KerastickTM)

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

Procedure: Fluorescence Diagnosis Imaging

FD Image taken prior to PDL-585 usage

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571974

Contacts

Contact: Linda Wood

501-526-7130

woodlindaj@uams.edu

Locations

United States, Arkansas
University of Arkansas for Medical Sciences	Recruiting
Little Rock, Arkansas, United States, 72205
Principal Investigator: Gal Shafirstein, PhD

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator:

Gal Shafirstein, PhD

University of Arkansas

More Information

Responsible Party:	University of Arkansas for Medical Sciences ( Carole Hamon )
Study ID Numbers:	51439
Study First Received:	December 5, 2007
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00571974
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Precancerous Conditions
Leukoplakia
Erythroplakia

Erythroplasia
Dental Caries
Aminolevulinic Acid

Additional relevant MeSH terms:

Photosensitizing Agents
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses

Physiological Effects of Drugs
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009