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

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 1

Conditions

Malignant Pleural Mesothelioma

Pleural Mesothelioma

Treatments

Drug: Cisplatin

Drug: Sodium Thiosulfate

Study type

Interventional

Funder types

Other

Identifiers

NCT00165555

99-124

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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