Status:
COMPLETED
Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma
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:
PHASE1
Brief Summary
The purpose of this study it to determine the safety and maximally tolerated dose (MTD) of cisplatin administered in the operating room and put into the chest and abdomen for one hour. We are also loo...
Detailed Description
* Patients will undergo surgery with pleurectomy/decortication which entails the removal of the inner and outer skin of the lung, including the pleura overlying the pericardium and diaphragm. Resectio...
Eligibility Criteria
Inclusion
- Histopathologic confirmation of malignant pleural mesothelioma
- Patients who are able to tolerate surgical cytoreduction but unable to undergo extrapleural pneumonectomy due to poor cardiopulmonary reserve or tumor invasion
- 18 years of age or older
- Malignancy is confined to the affected hemithorax.
- Grossly normal cardiac function with an EKG showing no cardiomyopathy or acute changes
- Evidence of adequate renal and hepatic function
- Karnofsky performance status of 70% or greater
Exclusion
- Extended disease outside the ipsilateral hemithorax as determined radiologically and intraoperatively
- Distant metastases
- Non-malignant systemic disease
- Active concomitant malignancy
- Psychiatric or addictive disorders which would preclude obtaining informed consent
- Prior treatment within the last 2 months, other than surgical resection for their current malignancy
Key Trial Info
Start Date :
August 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00165555
Start Date
August 1 1999
End Date
November 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