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Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma

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Malignant Pleural Mesothelioma

Estimated Enrollment: 141

Age Group: 18 Years and older   (Adult, Senior)

Gender: All

Study Type: Interventional

Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: Treatment

Study ID Numbers: 07-091

Study First Received: December 10, 2007

Last Updated: January 19, 2017

Estimated Primary Completion Date: November 2011

Primary Outcome Measures:

To establish the maximally tolerated dose (MTD) of intraoperative Intrathoracic/Intraperitoneal hyperthermic gemcitabine and cisplatin combination modulated by amifostine and sodium thiosulfate in patients with malignant pleural mesothelioma.|To determine and quantitate the safety of this combination in these patients by defining the dose limiting toxicity.|To study the pharmacokinetics of gemcitabine and cisplatin combination administered in this way.

Sponsors and Collaborators:

Brigham and Women’s Hospital|Dana-Farber Cancer Institute

Result Received: No Study Results Posted

Website Link: https://ClinicalTrials.gov/show/NCT00571298

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