Clinical Trial: Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase I Study of Photodynamic Therapy Using Pulsed Dye Laser and Oral Aminolevulinic Acid in Patients With Oral Leukoplakia

Brief Summary: This phase I trial studies the side effects and best dose of photodynamic therapy using aminolevulinic acid in treating patients with oral leukoplakia. Photodynamic therapy uses a drug, such as aminolevulinic acid, that becomes active when it is exposed to a certain kind of light. When the drug is active, abnormal cells are killed. Photodynamic therapy using aminolevulinic acid may be effective against oral leukoplakia.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the toxicity and feasibility of photodynamic therapy using pulsed laser therapy and oral aminolevulinic acid in treating patients with oral leukoplakia.

II. To define the dose-limiting toxicity and maximum tolerated dose of photodynamic therapy using pulsed laser therapy and oral aminolevulinic acid in these patients.

SECONDARY OBJECTIVES:

I. To assess the efficacy of photodynamic therapy using pulsed dye laser and oral aminolevulinic acid by examining clinical response at 1 and 3 months.

II. To determine quantitative histologic response at 3 months. III. To explore the association of response with specific molecular and biologic markers (i.e., DNA ploidy, proliferation using Ki-67, apoptosis using TUNEL, cyclin D1, and p53).

OUTLINE: This is a dose-escalation study of long pulsed dye laser light.

Patients receive aminolevulinic acid* orally (PO) 3-4 hours before undergoing photodynamic therapy using pulsed dye laser on day 1.

(Note: *Patients in cohort 1 and a latter cohort [to be determined during the course of the study] do not receive aminolevulinic acid before photodynamic therapy.)

Patients undergo biopsies of target lesions and clinically uninvolved mucosa 4-8 weeks before beginning therapy and then at 3 months for biomarker studies (DNA ploidy, p53, Ki-67, cyclin D1, and TUNEL assay). Blood is collected on days 1, 2, 14, 28, and 84 for toxicity assessment.

After completion of study treat
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Safety and tolerability with determination of optimal light dosing regimen, determination of dose limiting-toxicities, and maximum tolerated dose of photodynamic therapy using pulsed laser therapy and oral aminolevulinic acid [ Time Frame: Up to 84 days ]

Original Primary Outcome: Safety and tolerability with determination of optimal light dosing regimen, determination of dose limiting toxicities and maximum tolerated dose of photodynamic therapy using pulsed laser therapy and oral aminolevulinic acid

Current Secondary Outcome:

  • Clinical response [ Time Frame: 1 month ]
  • Clinical response [ Time Frame: 3 months ]
  • Histologic response [ Time Frame: 3 months ]
  • Mucosal risk marker modulation as measured by proliferation using Ki-67, apoptosis using TUNEL, cyclin D1, p53 expression, and DNA ploidy [ Time Frame: Up to 84 days ]


Original Secondary Outcome:

  • Clinical response at 1 and 3 months
  • Histologic response at 3 months
  • Mucosal risk marker modulation from baseline as measured by proliferation using Ki-67, apoptosis using TUNEL, cyclin D1, p53 expression, and DNA ploidy


Information By: National Cancer Institute (NCI)

Dates:
Date Received: December 11, 2007
Date Started: March 2008
Date Completion:
Last Updated: October 8, 2014
Last Verified: February 2013