Malignant Pleural Mesothelioma Clinical Trial
Official title:
A Phase II Feasibility Study of Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate
Verified date | March 2014 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 85 |
Est. completion date | December 2009 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To monitor tumor recurrence and patient survival, and compare those results to historic controls. | TBD | No | |
Secondary | To document the morbidity and mortality of this treatment protocol in this patient population | 3 years | Yes | |
Secondary | to evaluate the pharmacokinetics of cisplatin. | 3 years | No |
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