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

March 26, 2014 updated by: Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02115
    - Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the maximally tolerated dose of intracavitary cisplatin in patients with malignant pleural mesothelioma, Time Frame: 3 years	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To quantitate the safety of intraoperative intrathoracic/intraperitoneal hyperthermic cisplatin Time Frame: 3 years	3 years
to study the pharmacokinetics of cisplatin administered in this way. Time Frame: 3 years	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1999

Primary Completion (Actual)

April 1, 2002

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria