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

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ClinicalTrials.gov Identifier: NCT00165555
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : March 27, 2014
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date March 27, 2014
Study Start Date  ICMJE August 1999
Actual Primary Completion Date April 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)		 To determine the maximally tolerated dose of intracavitary cisplatin in patients with malignant pleural mesothelioma, [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)		 To determine the maximally tolerated dose of intracavitary cisplatin in patients with malignant pleural mesothelioma,
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • To quantitate the safety of intraoperative intrathoracic/intraperitoneal hyperthermic cisplatin [ Time Frame: 3 years ]
  • to study the pharmacokinetics of cisplatin administered in this way. [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • To quantitate the safety of intraoperative intrathoracic/intraperitoneal hyperthermic cisplatin
  • to study the pharmacokinetics of cisplatin administered in this way.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma
Official Title  ICMJE Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin and Intravenous Sodium Thiosulfate in the Multimodality Treatment of Malignant Pleural Mesothelioma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pleural Mesothelioma
  • Malignant Pleural Mesothelioma
Intervention  ICMJE
  • Drug: Cisplatin
    Given as a heated one-hour lavage to the hemithorax after surgery.
  • Drug: Sodium Thiosulfate
    Given intravenously over 6 hours after the cisplatin lavage.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2005)		 70
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date April 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00165555
Other Study ID Numbers  ICMJE 99-124
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dana-Farber Cancer Institute
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Dana-Farber Cancer Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Brigham and Women's Hospital
Investigators  ICMJE
Principal Investigator: David J. Sugarbaker, MD Brigham and Women's Hospital
PRS Account Dana-Farber Cancer Institute
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP