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Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin and Intravenous Sodium Thiosulfate in the Multimodality Treatment of Malignant Pleural Mesothelioma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Pleural Mesothelioma, Malignant Pleural Mesothelioma

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Trial Information

Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin and Intravenous Sodium Thiosulfate in the Multimodality Treatment of Malignant Pleural Mesothelioma


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximally tolerated dose of intracavitary cisplatin in patients with malignant pleural mesothelioma,

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

David J. Sugarbaker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital

Authority:

United States: Institutional Review Board

Study ID:

99-124

NCT ID:

NCT00165555

Start Date:

August 1999

Completion Date:

April 2010

Related Keywords:

  • Pleural Mesothelioma
  • Malignant Pleural Mesothelioma
  • cisplatin
  • pleurectomy
  • decortication
  • heated cisplatin
  • Mesothelioma

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115