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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
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
Roswell Park Cancer Institute
Buffalo, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Survival months
Time frame: 4 years
Progression-free survival months
Time frame: 4 years
Local Control
progression with death as a competing risk
Time frame: 4 years
Receipt of Pembrolizumab
Time frame: 4 years
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