Know Cancer

forgot password

A Phase II Feasibility Study of Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate

Phase 2
18 Years
Open (Enrolling)
Pleural Mesothelioma, Malignant Pleural Mesothelioma

Thank you

Trial Information

A Phase II Feasibility Study of Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate

- Patients will undergo surgery called extrapleural pneumonectomy which involves removal
of the lung, the lining of the lung, the covering of the heart, and the muscle that
separates the chest and abdomen. At the conclusion of the resection, if the patient
has less then 1 cm3 of residual gross disease in one or more areas, then the heated
chemotherapy lavage will begin. If more than this volume of disease is present, then
the patient will receive additional treatment off-study.

- The chemotherapy treatment consists of a one-hour lavage of the chest and abdomen
cavity with heated cisplatin given in the operating room through the surgical incision.
At the completion of the hour, sodium thiosulfate is given intravenously to reduce the
potential side effects of cisplatin.

- During the surgery and for four hours following the completion of the cisplatin lavage,
blood samples, urine samples, chest wall muscle samples, and samples of the
chemotherapy solution will be done in order to measure the concentration of
chemotherapy and the impact of cisplatin on the various cell samples.

- Patients will remain in the hospital until they have recovered from surgery (7-14
days). Following discharge from the hospital, patients will be seen 1-2 weeks
post-operatively for blood tests. 6 weeks later additional blood tests and and
echocardiogram will be performed. This echocardiogram will be repeated 6 months
post-operatively to re-assess heart function.

Inclusion Criteria:

- Male of non-pregnant female 18 years of age or older

- HIstopathologic confirmation of malignant pleural mesothelioma

- Ejection fraction > 45%

- Evidence of adequate renal and hepatic function

- Grossly normal contralateral pulmonary function with a chest radiograph and chest CT
scan that do not show acute infiltrates

- FEV1 > or = to 2.0L on a preoperative pulmonary function test

- Karnofsky performance status of 70% or greater

Exclusion Criteria:

- Extended disease outside the ipsilateral hemithorax as determined by pre-operative
radiographs or intraoperative findings

- Positive extrapleural nodes as determined by mediastinoscopy

- Positive LENIs

- Gross disease present within the hemithorax after surgery

- Evidence of distant metastases

- Severe non-malignant co-morbid disease: uncontrolled angina, myocardial infarction in
the past 6 months, renal insufficiency, liver disease, pulmonary hypertension

- Presence of active concomitant malignancy

- Patients with a psychiatric or addictive disorder which would preclude informed

- Previous chemotherapy or radiation therapy to treat mesothelioma

- Chemotherapy or radiation therapy administered within 3 years for another malignancy

Type of Study:


Study Design:

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

Outcome Measure:

To monitor tumor recurrence and patient survival, and compare those results to historic controls.

Outcome Time Frame:


Safety Issue:


Principal Investigator

David J. Sugarbaker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

January 2004

Completion Date:

January 2010

Related Keywords:

  • Pleural Mesothelioma
  • Malignant Pleural Mesothelioma
  • Extrapleural pneumonectomy
  • cisplatin
  • heated cisplatin
  • Mesothelioma



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115