Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma
Completed · Phase 1
Conditions studied: Pleural Mesothelioma, Malignant Pleural Mesothelioma
In brief
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 looking at the effects of heating the chemotherapy to a temperature of 42 degrees celsius.
Key facts
- Study ID
- NCT00165555
- Run by
- Dana-Farber Cancer Institute
- People needed
- 70
- Starts
- 1999-08-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2014-03-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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