NCT02153229

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epitheliod Malignant Pleural Mesothelioma

Interventions

Type	Name	Description
RADIATION	Photodynamic Therapy
PROCEDURE	Radical Pleurectomy
RADIATION	Chemotherapy
DRUG	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

Timeline

• Start date: 2014-06-02
• Primary completion: 2026-12-16
• Completion: 2027-12-01
• First posted: 2014-06-03
• Last updated: 2025-12-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study