NCT00453336

Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract

A Phase II Clinical Trial on the Efficacy of Photodynamic Therapy With Porfimer Sodium (Photofrin®) for Malignant and Pre-Malignant Lesions and Condemned Mucosa Syndrome in the Upper Aerodigestive Tract

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Miami · 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, precancerous cells and cancer cells are killed. PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy with porfimer sodium works in treating patients with precancerous lesions, cancer, or other disease of the aerodigestive tract.

Detailed description

OBJECTIVES: * Determine the efficacy of photodynamic therapy with porfimer sodium in patients with pre-malignant lesions, carcinoma in situ, select superficial squamous cell carcinoma of the oral cavity, oropharynx, or larynx, or condemned mucosa syndrome in the upper aerodigestive tract. * Determine the safety of this regimen in these patients. OUTLINE: Patients are stratified according to disease condition (benign vs malignant). Patients receive porfimer sodium IV over 3-5 minutes on day 1 and laser light activation on day 3 or 4. After completion of study treatment, patients are followed at 3 and 4 months and then periodically for up to 2 years. PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

Conditions

• Head and Neck Cancer
• Precancerous/Nonmalignant Condition

Interventions

Type	Name	Description
DRUG	Porfimer Sodium	Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.
PROCEDURE	Photodynamic Therapy	Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.

Timeline

• Start date: 2003-06-01
• Primary completion: 2009-08-01
• Completion: 2010-05-01
• First posted: 2007-03-28
• Last updated: 2017-02-08
• Results posted: 2013-10-18

Locations

1 site across 1 country: United States