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ACTIVE NOT RECRUITING
NCT02153229
PHASE2

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

Sponsor: Abramson Cancer Center at Penn Medicine

View on ClinicalTrials.gov

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

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

Locations (2)

Roswell Park Cancer Institute

Buffalo, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States