Phase II, A Study of Lung-Sparing Combined Modality Protocol for the Treatment for Malignant Pleural Mesothelioma: The Columbia Protocol
Current surgical and/or chemotherapeutic approaches for malignant pleural mesothelioma are
unsatisfactory and have not been shown to significantly prolong survival, and often lead to
worsened pulmonary function and quality of life. We will investigate whether a prospective
trial of trimodal (surgery, pleural chemotherapy, and pleural radiation) therapy can improve
the overall 1 year survival in patients with malignant pleural mesothelioma. The proposed
treatment will include exploratory thoracoscopy, placement of Mediport catheters into the
pleural space, intraoperative chemotherapy, repeated intraperitoneal chemotherapy, and
intrapleural instillation of radioactive P32 to radiate the pleural surfaces. In addition,
because this study is randomized, half the patients will receive an additional three
intravenous systemic chemotherapy treatments of cisplatin and pemetrexed (Alimta) in tandem
with their intrapleural chemotherapy (weeks 3, 6, and 9 only).
The potential significance of this research is that such treatment may render it less
necessary to surgically remove the affected lungs in whole or in part, in order to achieve
significant disease cytoreduction. We hope to alter the currently accepted paradigm that
major lung surgery is an inescapable component of such treatment, and advance the concept
that a combination of judicious preparative surgery, systemic chemotherapy, and locoregional
drug treatment of the pleural surfaces may offer the best hope for prolongation of survival
with intact lung function.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the feasibility of multimodal lung sparing regimen
Intrapleural chemotherapy (12 weeks) will be administered within two weeks after surgery. Approximately 30 days post last dose of chemotherapy (+/- 14 days), the patient should be reassessed for resolution of any treatment-related toxicity which may have occurred during the course of study participation.
20 weeks
Yes
Robert N Taub, MD, PhD
Principal Investigator
Columbia University
United States: Institutional Review Board
AAAB9658 (A6)
NCT00859495
February 2008
December 2014
Name | Location |
---|---|
Columbia University Medical Center | New York, New York 10032 |