Phase II Trial of Radical Pleurectomy With or Without Intraoperative PDT for Malignant Pleural Mesothelioma (MPM-PDT)

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

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 Overview

• Status: Recruiting
• Conditions: Epitheliod Malignant Pleural Mesothelioma
• Intervention / Treatment: Radiation: Photodynamic Therapy; Procedure: Radical Pleurectomy; Radiation: Chemotherapy; Drug: Photofrin 2.0 mg/kg

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sally McNulty, RN; Phone Number: 215-662-7720; Email: Sally.McNulty@uphs.upenn.edu

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Rosewell Park
      • Principal Investigator: Sai Yendamuri, MD
      • Contact: Kelly Dunn, MPH, CCRP; Phone Number: 6537 716-845-1300; Email: kelly.dunn@roswellpark.org
      • Contact: Elongia Farrell, BA, CCRC; Phone Number: 716-845-3114; Email: elongia.farrell@roswellpark.org
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Abramson Cancer Center of the University of Pennsylvania
      • Contact: Sally McNulty, RN; Phone Number: 215-662-7720; Email: Sally.McNulty@uphs.upenn.edu
      • Contact: Keith Cengel, MD, PhD; Phone Number: 855-216-0098; Email: PennCancerTrials@emergingmed.com
      • Principal Investigator: Keith Cengel, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with a histologic diagnosis of MPM, epithelioid subtype, who in the opinion of the attending thoracic surgeon can receive a macroscopically complete resection of tumor.
• Patients must have disease limited to the hemithorax.
• Patients who have received prior surgery, gene therapy, or combination chemotherapy will be permitted if it has been at least 30 days since the last treatment.
• Subjects treated with pemetrexed previously will be eligible only if 30 days have elapsed between the last dose of pemetrexed and the date of surgery.
• ECOG performance status of 0-1.
• Medical suitability for resection, including documented medical and cardiac clearance.
• 18 years of age or older.
• Patients must sign a document that indicates that they are aware of the investigative nature of the treatment of this protocol, and the potential benefits and risks. Patients unwilling or unable due to cognitive impairment to sign informed consent are excluded from the study.

EXCLUSION CRITERIA

• Patients with active invasive cancers, other than MPM, that require additional treatment, except non-melanomatous skin cancer, superficial bladder or cervical cancer, and early-stage prostate cancer
• Pregnant or lactating patients.
• Patients who have a history of HIV disease.
• Patients who have a white count less than 2,500 per cubic mm or platelets less than 100,000/cubic mm.
• Serum creatinine equal or greater than 2.5 mg/deciliter.
• Patients who have severe liver disease including cirrhosis, Grade III-IV elevations in liver function studies, or bilirubin in excess of 1.5 mg/deciliter.
• Patients with porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
• Patients who have been treated with pemetrexed if the last dose of pemetrexed is < 30 days to the date of surgery.
• Patients that have been treated with prior Mantle field radiation.
• Patients with distant metastatic disease or otherwise not confined to the ipsilateral hemithorax.
• Subjects who have received more than 2 doses of neo-adjuvant chemotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients who undergo RP plus photofrin-based PDT	Radiation: Photodynamic Therapy; Other Names: PDT; Procedure: Radical Pleurectomy; Other Names: RP; 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
Experimental: patients who undergo RP alone	Procedure: Radical Pleurectomy; Other Names: RP; Radiation: Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival months	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival months		4 years
Local Control	progression with death as a competing risk	4 years
Receipt of Pembrolizumab		4 years

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Keith Cengel, MD, PhD, Abramson Cancer Center at Penn Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 28, 2014
• First Submitted That Met QC Criteria: June 2, 2014
• First Posted (Estimated): June 3, 2014

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Histological diagnosis of MPM; epitheliod subtype; limited to the hemithorax; macroscopically complete resection of the tumor
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Mesothelioma; Mesothelioma, Malignant; Antineoplastic Agents; Photosensitizing Agents; Dermatologic Agents; Dihematoporphyrin Ether
• Other Study ID Numbers: UPCC 14513