Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
NCT ID: NCT00054002
Last Updated: 2011-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
1999-03-31
2010-12-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining photodynamic therapy with surgery in treating patients who have malignant mesothelioma.
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Detailed Description
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* 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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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adjuvant therapy
Lung surgery
conventional surgery
Lung surgery
porfimer sodium
iv
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Roswell Park Cancer Institute
Principal Investigators
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Todd L. Demmy, MD
Role: STUDY_CHAIR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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RPCI-RP-9812
Identifier Type: -
Identifier Source: secondary_id
CDR0000269674
Identifier Type: -
Identifier Source: org_study_id
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