Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
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|ClinicalTrials.gov Identifier: NCT00054002|
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : March 1, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma||Procedure: adjuvant therapy Procedure: conventional surgery Drug: porfimer sodium||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers|
|Study Start Date :||March 1999|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||December 2010|
- Procedure: adjuvant therapy
- Procedure: conventional surgery
- Drug: porfimer sodium
- Feasibility [ Time Frame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years ]
- Comparison of results from this regimen to historical controls [ Time Frame: At completion of study ]
- Toxic effects [ Time Frame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054002
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Todd L. Demmy, MD||Roswell Park Cancer Institute|