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