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
- 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
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall clinical response rate (complete and partial response) at 3 and 4 months after completion of study treatment
3 and 4 months after completion of study treatment
Francisco Civantos, Jr., MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|