Malignant Mesothelioma Clinical Trial
Official title:
Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive
to light to kill cancer cells. Combining photodynamic therapy with surgery may be an
effective treatment for malignant mesothelioma.
PURPOSE: Phase II trial to study the effectiveness of combining photodynamic therapy with
surgery in treating patients who have malignant mesothelioma.
OBJECTIVES:
- 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
years.
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
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