A Phase II Study of the Safety and Efficacy of Photodynamic Therapy in Carcinoma in Situ of the Esophagus
OBJECTIVES: I. Evaluate the efficacy of photodynamic therapy (PDT) using porfimer sodium
(Photofrin) and controlled uniform laser light in patients with carcinoma in situ in
Barrett's esophagus or severe dysplasia in Barrett's esophagus. II. Evaluate the safety of
the treatment on this patient.
OUTLINE: This is a noncomparative study. PDT consists of IV porfimer sodium followed 40-50
hours later by laser red light delivered by optic fibers passed through the biopsy channel
of an endoscope. Retreatment, if necessary, consists of up to 3 injections at least 30 days
apart and up to 6 laser light treatments, with a maximum of 2 following each injection.
Patients are followed monthly for 4 months, and then periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hector R. Nava, MD, FACS
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|