Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of this study are: to evaluate the effects (good and bad) that administering heated cisplatin into the chest and abdomen cavity following surgical resection has on malignant mesothelioma; to collect data on the toxicity of cisplatin given directly into the chest and abdomen, and the levels of the cisplatin in the body; to determine if this treatment method has the possibility of helping patients with pleural mesothelioma live longer; and to determine if this treatment method can help decrease the rate of local recurrence of mesothelioma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: Brigham and Women's Hospital
• Treatments: Amifostine; Cisplatin; Sodium thiosulfate

Criteria

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 consent

• Previous chemotherapy or radiation therapy to treat mesothelioma

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