Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malignant Mesothelioma

Intervention / Treatment
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* Procedure: adjuvant therapy
* Procedure: conventional surgery
* Drug: porfimer sodium


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignant mesothelioma, including the following cell types: Mixed mesothelial Sarcomatous Stage I or II disease using the Butchart system as determined by CT scan or MRI Disease confined to 1 hemithorax No tumor involvement of esophagus or heart as evidenced by CT scan Pericardial or diaphragmatic involvement allowed if disease is limited to the ipsilateral chest N2 disease allowed if no contralateral pleural involvement No adenocarcinoma or nonmesothelioma sarcoma of the chest wall PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic WBC greater than 4,000/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 8.5 g/dL (transfusion allowed) Hepatic Bilirubin less than 3.0 mg/dL Alkaline phosphatase less than 2 times upper limit of normal (ULN) SGOT less than 2 times ULN Renal Creatinine less than 3.0 mg/dL Cardiovascular No myocardial infarction within the past 6 months Pulmonary Arterial partial pressure of carbon dioxide (pCO_2) less than 50 torr at rest Predicted postoperative FEV_1 at least 800 mL with maximum oxygen consumption/kg at least 15 mL/min Predicted postoperative total lung capacity at least 40% of hemoglobin and alveolar ventilation Other Not pregnant No other concurrent malignancy except nonmelanoma skin cancer No contraindication to general anesthetic No history of porphyria No indicated sensitivity to porfimer sodium PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy More than 30 days since prior chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy to the chest No prior radiotherapy for mesothelioma Surgery Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: adjuvant therapy|Lung surgery|
|Procedure: conventional surgery|Lung surgery|
|Drug: porfimer sodium|iv|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility |  | 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 |  | At completion of study | 
| Toxic effects |  | 1 month, every 4 months for 2 years, and then every 6 months for 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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localized malignant mesothelioma, recurrent malignant mesothelioma, epithelial mesothelioma, sarcomatous mesothelioma