Expired Study
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Buffalo, New York 14263


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00054002


Primary Contact:

Study Chair
Todd L. Demmy, MD
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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