NCT00054002

Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Mesothelioma

Interventions

Type	Name	Description
PROCEDURE	adjuvant therapy	Lung surgery
PROCEDURE	conventional surgery	Lung surgery
DRUG	porfimer sodium	iv

Timeline

• Start date: 1999-03-01
• Primary completion: 2006-06-01
• Completion: 2010-12-01
• First posted: 2003-02-06
• Last updated: 2011-03-01

Locations

1 site across 1 country: United States