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

Malignant Pleural Mesothelioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165555
• Other study ID #: 99-124
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: March 26, 2014
• Start date: August 1999
• Est. completion date: November 2009

Study information

• Verified date: March 2014
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2009
• Est. primary completion date: April 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Pleural Mesothelioma
• Mesothelioma
• Pleural Mesothelioma

Intervention

Drug:
• Cisplatin
Given as a heated one-hour lavage to the hemithorax after surgery.
• Sodium Thiosulfate
Given intravenously over 6 hours after the cisplatin lavage.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximally tolerated dose of intracavitary cisplatin in patients with malignant pleural mesothelioma,		3 years	Yes
Secondary	To quantitate the safety of intraoperative intrathoracic/intraperitoneal hyperthermic cisplatin		3 years	Yes
Secondary	to study the pharmacokinetics of cisplatin administered in this way.		3 years	No