Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pleural Mesothelioma Malignant Pleural Mesothelioma	Drug: Cisplatin Drug: Sodium Thiosulfate	Phase I

MedlinePlus related topics:

Mesothelioma

Drug Information available for:

Cisplatin Sodium thiosulfate Sodium hyposulfite

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study

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

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine the maximally tolerated dose of intracavitary cisplatin in patients with malignant pleural mesothelioma, [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To quantitate the safety of intraoperative intrathoracic/intraperitoneal hyperthermic cisplatin [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
to study the pharmacokinetics of cisplatin administered in this way. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	August 1999
Estimated Study Completion Date:	April 2009
Primary Completion Date:	April 2002 (Final data collection date for primary outcome measure)

Intervention Details:

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

Given intravenously over 6 hours after the cisplatin lavage.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165555

Locations


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

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators


Principal Investigator:	David J. Sugarbaker, MD	Brigham and Women's Hospital

More Information

Responsible Party:	Brigham and Women's Hospital ( David Sugarbaker, MD )
Study ID Numbers:	99-124
First Received:	September 12, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00165555
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

cisplatin

pleurectomy

decortication

heated cisplatin

Study placed in the following topic categories:

Cisplatin

Sodium thiosulfate

Mesothelioma

Adenoma

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents

Neoplasms by Histologic Type

Antioxidants

Molecular Mechanisms of Pharmacological Action

Neoplasms, Mesothelial

Antineoplastic Agents

Physiological Effects of Drugs

Protective Agents

Pharmacologic Actions

Anti-Bacterial Agents

Neoplasms

Radiation-Sensitizing Agents

Therapeutic Uses

Chelating Agents

Antitubercular Agents

Antidotes

ClinicalTrials.gov processed this record on October 24, 2008

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00165555