Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers
- Determine the feasibility of adjuvant photodynamic therapy with large diffuser fibers
in patients with malignant mesothelioma undergoing surgery.
- Compare results of this regimen in these patients to historical controls.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a pilot study.
Patients receive porfimer sodium IV over 5-10 minutes on day 1. Patients undergo pleurectomy
or pleuropneumonectomy followed by intracavitary photodynamic therapy on day 3.
Patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 3
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1 month, every 4 months for 2 years, and then every 6 months for 3 years
Todd L. Demmy, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|