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

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

June 30, 2003

Primary Completion Date

August 31, 2009

Study Completion Date

May 31, 2010

Conditions
Head and Neck CancerPrecancerous/Nonmalignant Condition
Interventions
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.

Trial Locations (1)

33136

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami

All Listed Sponsors
lead

University of Miami

OTHER

NCT00453336 - Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract | Biotech Hunter | Biotech Hunter