NCT00859495

Trimodal Lung-Sparing Treatment of Pleural Mesothelioma

Phase II, A Study of Lung-Sparing Combined Modality Protocol for the Treatment for Malignant Pleural Mesothelioma: The Columbia Protocol

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pleural Mesothelioma

Interventions

Type	Name	Description
DRUG	Doxorubicin	A medication used in cancer chemotherapy, derived by chemical semisynthesis from a bacterial species.
DRUG	Cisplatin	Platinum-based antineoplastic
DRUG	Pemetrexed	Folate Analog Metabolic Inhibitor
RADIATION	Radiotherapy	Standard procedure given 3 weeks after last dose of chemotherapy

Timeline

• Start date: 2008-02-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2009-03-11
• Last updated: 2020-08-25
• Results posted: 2020-08-25

Locations

1 site across 1 country: United States