Expired Study
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Little Rock, Arkansas 72205


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.


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


NCT ID:

NCT00571974


Primary Contact:

Principal Investigator
Gal Shafirstein, PhD
University of Arkansas


Backup Contact:

N/A


Location Contact:

Little Rock, Arkansas 72205
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 16, 2017

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