Professional Abstract - Trimodal Treatment Test in Columbia Protocol

Technical Abstract - A Randomized, Phase II, Lung-sparing combined modality protocol for the treatment of malignant pleural mesothelioma: The Columbia Protocol

It is proposed to test the feasibility and effectiveness of an intensive trimodal locoregional lung-sparing treatment regimen in selected patients with mesothelioma. Eligible patients will undergo initial exploratory thoracoscopic surgery with intraoperative intrapleural chemotherapy and placement of intrapleural mediport-attached catheters to provide continual access to the pleural space. All patients will then be given repeated outpatient intrapleural chemotherapy with doxorubicin (at non-cardiotoxic cumulative doses) and cisplatin (weeks 1, 2, 4, 5, 7, and 8) Patients will be randomized to receive additional chemotherapy with intravenous cisplatin and pemetrexed during weeks 3, 6, and 9 (Arm A), or the same chemotherapy given optionally, but delayed until after all other procedures are completed (Arm B); in this manner we hope to learn whether surgically documented regression of disease can be achieved using local therapy only. At week 12 all patients will be given outpatient intrapleural P32 radiotherapy as feasible. A second exploratory thoracoscopy will then be performed with intraoperative intrapleural chemotherapy and removal of the pleural catheters. This will complete the study procedures. Patients may then elect to undergo additional surgery (extrapleural pneumonectomy or radical pleurectomy/decortication) or for EPP patients, additional elective external beam radiotherapy. Patients assigned to Arm B, now off-study, may elect to receive systemic Cisplatin and pemetrexed in the outpatient treatment center.

Using histochemical and molecular techniques, we will quantify DNA adduct formation and the depth and intensity of platinum penetration into biopsied pleural tissues after the first and subsequent intracavitary cisplatin treatments. We will similarly assay the depth and type of tissue alteration and DNA damage induced by intracavitary P32 radiation treatment.

This clinical trial is meant to demonstrate that a regimen of locoregional combined surgery, chemotherapy and radiation can be sufficient to eradicate mesothelioma that is restricted to pleural surfaces, and can prolong the time to recurrence and overall survival comparable to that achievable with EPP, but without removal or destruction of the affected lung.

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