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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00571974
Other study ID # 51439
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received December 5, 2007
Last updated March 4, 2015
Start date January 2007
Est. completion date January 2012

Study information

Verified date March 2015
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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 solution); 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

Locations

Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (1)

Shafirstein G, Friedman A, Siegel E, Moreno M, Bäumler 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) — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose The traditional 3+3 dose escalation design was employed. Three cohorts were enrolled at 3 subjects per cohort, and treated with escalating radiant exposures of 6, 7, or 8 J/cm2. In each cohort, the number of dose-limiting toxicities (DLTs) were observed. Dose escalation rules were the same as those provided by Storer 1989. Day 2 Yes
Primary The Objective Response Rate is the Number of Participants With Significant Response (SR), Partial Response (PR) or No Response (NR). The response rate was quantified by examination by an experienced head and neck surgeon and classified as follows: significant response (SR) was one where the lesion had greater than 75% resolution, partial response (PR) was one in which the lesion was reduced in size by at least 25%, and no response (NR) was one where the lesion was reduced by less than 25% in size. Day 90 No
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