Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate
Completed · Phase 2
Conditions studied: Pleural Mesothelioma, Malignant Pleural Mesothelioma
In brief
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.
Key facts
- Study ID
- NCT00165516
- Run by
- Dana-Farber Cancer Institute
- People needed
- 85
- Starts
- 2004-01-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2014-03-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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