Clinical trial NCT00165555: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pleural Mesothelioma
Malignant Pleural Mesothelioma
Keywords: cisplatin
pleurectomy
decortication
heated cisplatin
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2005-09-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To determine the maximally tolerated dose of intracavitary cisplatin in patients with malignant pleural mesothelioma,
timeFrame: 3 years
Secondary outcomes:
measure: To quantitate the safety of intraoperative intrathoracic/intraperitoneal hyperthermic cisplatin
timeFrame: 3 years
measure: to study the pharmacokinetics of cisplatin administered in this way.
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: David J. Sugarbaker, MD
role: PRINCIPAL_INVESTIGATOR
References: