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Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma



Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

For Condition: epithelial mesothelioma,localized malignant mesothelioma,recurrent malignant mesothelioma,sarcomatous mesothelioma
Status: Recruiting
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ToddDemmy,  Study Chair,  Roswell Park Cancer Institute

Roswell Park Cancer Institute *Recruiting*
Buffalo,  New York,  14263-0001
United States
Recruiting Todd  Demmy 716-845-5873


Additional Information:
Study ID Numbers:  CDR0000269674;  RPCI-RP-9812
Study Start Date: 
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054002

Other Sarcomatous Mesothelioma Studies:
1. Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma

2. PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma

3. ZD 1839 in Treating Patients With Malignant Mesothelioma

4. Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

5. Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma

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