Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract
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.
Head and Neck Cancer
Drug: Porfimer Sodium
Procedure: Photodynamic Therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.
- Number of Participants Experiencing Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Number of participants enrolled experiencing serious adverse events and/or other non-serious events
|Study Start Date:||June 2003|
|Study Completion Date:||May 2010|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
|Experimental: Single Arm||
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.
Other Name: PhotofrinProcedure: 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.
Other Name: Microlens Diffuser P/N 5416
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453336
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|Study Chair:||Francisco Civantos, Jr., MD||University of Miami Sylvester Comprehensive Cancer Center|