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

NCT ID: NCT00165555

Last Updated: 2014-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-08-31
• Study Completion Date: 2009-11-30

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cisplatin

Given as a heated one-hour lavage to the hemithorax after surgery.

Intervention Type: DRUG

Sodium Thiosulfate

Given intravenously over 6 hours after the cisplatin lavage.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J. Sugarbaker, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

99-124

Identifier Type: -

Identifier Source: org_study_id