Spots Global Cancer Trial Database for Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors

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Trial Identification

Brief Title: Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors

Official Title: Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors

Study ID: NCT00978081

Conditions

Head and Neck Cancer

Precancerous Condition

Interventions

aminolevulinic acid hydrochloride

Study Description

Brief Summary: RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. PURPOSE: This randomized phase I trial is studying the side effects and best dose of photodynamic therapy in treating patients with premalignant or early stage head and neck tumors.

Detailed Description: OBJECTIVES: Primary * To evaluate the toxicities associated with aminolevulinic acid-mediated photodynamic therapy when administered continuously or in fractionated doses in patients with premalignant or early stage head and neck lesions. Secondary * To assess the efficacy of this regimen in these patients. OUTLINE: This is a dose-escalation study of photodynamic therapy. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later. * Arm II: Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later. After completion of study therapy, patients are followed up at 1 month, every 3 months for 2 years, and then annually thereafter.