Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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 looking at the effects of heating the chemotherapy to a temperature of 42 degrees celsius.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: Brigham and Women's Hospital
• Treatments: Cisplatin; Sodium thiosulfate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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