NCT00165555

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

Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin and Intravenous Sodium Thiosulfate in the Multimodality Treatment of Malignant Pleural Mesothelioma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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. Resection of the pericardium and diaphragm are occasionally necessary to debulk the tumor. This surgery is part of standard care for pleural mesothelioma. * After surgery, a one hour lavage with heated cisplatin will be administered to the hemithorax (and abdominal regions if the diaphragm is no longer present). The lung itself is not removed, only the diseased portion of the lung and surrounding areas with tumor. * Immediately following the one-hour lavage, a six hour infusion of sodium thiosulfate will begin to help reduce the side effects of the cisplatin. * Patients will remain hospitalized until they have recovered from surgery (usually 7-14 days). * Patients will return to the hospital three months after their surgery to have fluid drawn from their chest via an ultrasound guided thoracentesis. This is called a saline wash. * Patients will be in the study actively for three months. This includes a 2-week and 4-week post-operative follow-up in which blood work is performed. As well as a 3-month follow-up for the saline wash. Long-term follow-up includes computed tomography of the chest and abdomen every 6 months to assess recurrence.

Conditions

• Pleural Mesothelioma
• Malignant Pleural Mesothelioma

Interventions

Type	Name	Description
DRUG	Cisplatin	Given as a heated one-hour lavage to the hemithorax after surgery.
DRUG	Sodium Thiosulfate	Given intravenously over 6 hours after the cisplatin lavage.

Timeline

• Start date: 1999-08-01
• Primary completion: 2002-04-01
• Completion: 2009-11-01
• First posted: 2005-09-14
• Last updated: 2014-03-27

Locations

2 sites across 1 country: United States