Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
Study NCT ID:
NCT00859495
Status:
TERMINATED
Last Update Posted:
2020-08-25
First Post:
2009-03-09
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trimodal Lung-Sparing Treatment of Pleural Mesothelioma
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Phase II, A Study of Lung-Sparing Combined Modality Protocol for the Treatment for Malignant Pleural Mesothelioma: The Columbia Protocol
Status:
TERMINATED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to determine the feasibility (as determined by lack of serious adverse events) and tolerability (as determined by patient's ability to complete the study) of a multimodal lung sparing regimen of surgery, interpleural and intravenous chemotherapy, and local P-32 irradiation for malignant pleural mesothelioma.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: