Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165555
Status:
COMPLETED
Last Update Posted:
2014-03-27
First Post:
2005-09-12
Brief Title:
PleurectomyDecortication Followed by IntrathoracicIntraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
PleurectomyDecortication Followed by IntrathoracicIntraperitoneal Heated Cisplatin and Intravenous Sodium Thiosulfate in the Multimodality Treatment of Malignant Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 looking at the effects of heating the chemotherapy to a temperature of 42 degrees celsius
Detailed Description:
Patients will undergo surgery with pleurectomydecortication 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None