Phase I Study of Photodynamic Therapy Using Pulsed Dye Laser and Oral Aminolevulinic Acid in Patients With Oral Leukoplakia
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.
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
After completion of study treatment, patients are followed for up to 84 days.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Up to 84 days
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
|Robert H. Lurie Comprehensive Cancer Center||Chicago, Illinois 60611|