drugset / Trial / NCT02153229

Phase II Trial of Radical Pleurectomy With or Without Intraoperative PDT for Malignant Pleural Mesothelioma

NCT02153229

Phase 2 Active not recruiting 52 enrolled Abramson Cancer Center at Penn Medicine
RandomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-06-02
Primary completion
2026-12-16
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject porfimer sodium Small molecule 2 mg/kg Intravenous