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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02153229
Recruitment Status : Suspended (Covid-19)
First Posted : June 3, 2014
Last Update Posted : September 25, 2020
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Epitheliod Malignant Pleural Mesothelioma Radiation: Photodynamic Therapy Procedure: Radical Pleurectomy Radiation: Chemotherapy Drug: Photofrin 2.0 mg/kg Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2014
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
Experimental: patients who undergo RP plus photofrin-based PDT Radiation: Photodynamic Therapy
Other Name: PDT

Procedure: Radical Pleurectomy
Other Name: 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 Name: RP

Radiation: Chemotherapy

Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02153229

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United States, New York
Rosewell Park
Buffalo, New York, United States, 14263
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
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Principal Investigator: Keith Cengel, MD, PhD Abramson Cancer Center of the University of Pennsylvania
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT02153229    
Other Study ID Numbers: UPCC 14513
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Histological diagnosis of MPM
epitheliod subtype
limited to the hemithorax
macroscopically complete resection of the tumor
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Dihematoporphyrin Ether
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents