Photodynamic Therapy With Photofrin® for Treatment of Dysplasia, Carcinoma In Situ and Stage I Carcinoma of the Oral Cavity and the Larynx: A Pilot Study
- To determine the response of patients with recurrent dysplasia, squamous cell carcinoma
in situ, or stage I squamous cell carcinoma of the oral cavity or the larynx treated
with photodynamic therapy using porfimer sodium.
- To identify the local toxicity of this treatment in these patients.
OUTLINE: Patients receive porfimer sodium subcutaneously followed by photodynamic therapy
(PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of
dysplasia) fiberoptic lens fiber. Patients with incompletely treated or missed sites of
disease may receive another dose of laser light on day 5 without additional porfimer sodium.
Patients with multicentric disease may undergo additional PDT at least 4-6 weeks after the
After completion of study therapy, patients are followed for 1-2 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Nestor R. Rigual, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|