Status:
COMPLETED
Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Pleural Mesothelioma
Malignant Pleural Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purposes of this study are: to evaluate the effects (good and bad) that administering heated cisplatin into the chest and abdomen cavity following surgical resection has on malignant mesothelioma;...
Detailed Description
* Patients will undergo surgery called extrapleural pneumonectomy which involves removal of the lung, the lining of the lung, the covering of the heart, and the muscle that separates the chest and abd...
Eligibility Criteria
Inclusion
- Male of non-pregnant female 18 years of age or older
- HIstopathologic confirmation of malignant pleural mesothelioma
- Ejection fraction \> 45%
- Evidence of adequate renal and hepatic function
- Grossly normal contralateral pulmonary function with a chest radiograph and chest CT scan that do not show acute infiltrates
- FEV1 \> or = to 2.0L on a preoperative pulmonary function test
- Karnofsky performance status of 70% or greater
Exclusion
- Extended disease outside the ipsilateral hemithorax as determined by pre-operative radiographs or intraoperative findings
- Positive extrapleural nodes as determined by mediastinoscopy
- Positive LENIs
- Gross disease present within the hemithorax after surgery
- Evidence of distant metastases
- Severe non-malignant co-morbid disease: uncontrolled angina, myocardial infarction in the past 6 months, renal insufficiency, liver disease, pulmonary hypertension
- Presence of active concomitant malignancy
- Patients with a psychiatric or addictive disorder which would preclude informed consent
- Previous chemotherapy or radiation therapy to treat mesothelioma
- Chemotherapy or radiation therapy administered within 3 years for another malignancy
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00165516
Start Date
January 1 2004
End Date
December 1 2009
Last Update
March 27 2014
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115