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Phase II Trial of Radical Pleurectomy With or Without Intraoperative PDT for Malignant Pleural Mesothelioma
Sponsor: Abramson Cancer Center at Penn Medicine
Summary
A randomized Phase II trial to test whether the addition of intraoperative Photofrin-mediated photodynamic therapy to radical pleurectomy and post-operative chemo.improves OS in the treatment of patients with epithelioid MPM. Subjects assigned to the PDT arm will be given the photosensitizer prior to surgery . All subjects will receive maximal surgical debulking. Subjects in the PDT arm will receive intraoperative treatment using real-time, isotropic light dosimetry.
Official title: A Randomized Phase 2 Trial of Radical Pleurectomy and Post-Operative Chemotherapy With or Without Intraoperative Porfimer Sodium -Mediated Photodynamic Therapy for Patients With Epitheliod Malignant Pleural Mesothelioma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2014-06-02
Completion Date
2027-12
Last Updated
2025-12-26
Healthy Volunteers
No
Interventions
Photodynamic Therapy
Radical Pleurectomy
Chemotherapy
Photofrin 2.0 mg/kg
If randomized to the RP with PDT arm, subject will receive Photofrin 2.0 mg/kg as an intravenous infusion 24 hours (range 18-30 hours) prior to intra-operative light delivery (PDT) during radical pleurectectomy
Locations (2)
Roswell Park Cancer Institute
Buffalo, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States