NCT00978081

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

Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer
• Precancerous Condition

Interventions

Type	Name	Description
DRUG	aminolevulinic acid hydrochloride	Patients undergo continuous or fractionated photodynamic therapy.

Timeline

• Start date: 2009-01-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2009-09-16
• Last updated: 2019-04-23

Locations

1 site across 1 country: United States