Brief Title
Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma
Official Title
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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
To determine the maximally tolerated dose of intracavitary cisplatin in patients with malignant pleural mesothelioma,
Secondary Outcome
To quantitate the safety of intraoperative intrathoracic/intraperitoneal hyperthermic cisplatin
Condition
Pleural Mesothelioma
Intervention
Cisplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
70
Start Date
August 1999
Completion Date
November 2009
Primary Completion Date
April 2002
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
David J. Sugarbaker, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00165555
Organization ID
99-124
Responsible Party
Sponsor
Study Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital
Study Sponsor
David J. Sugarbaker, MD, Principal Investigator, Brigham and Women's Hospital
Verification Date
March 2014