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

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

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin and Intravenous Sodium Thiosulfate in the Multimodality Treatment of Malignant Pleural Mesothelioma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mesothelioma

Drug Information available for: Sodium thiosulfate Cisplatin Sodium hyposulfite

U.S. FDA Resources

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 2010
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

No publications provided

Responsible Party:	David Sugarbaker, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00165555 History of Changes
Other Study ID Numbers:	99-124
Study First Received:	September 12, 2005
Last Updated:	October 30, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

cisplatin
pleurectomy
decortication
heated cisplatin

Additional relevant MeSH terms:

Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Cisplatin
Sodium thiosulfate
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Antidotes

ClinicalTrials.gov processed this record on February 12, 2012