MPM PDT Phase II Trial



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/8/2016
Start Date:May 2014
Contact:Sally McNulty, RN
Email:Sally.Mcnulty@uphs.upenn.edu
Phone:215-662-7720

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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.


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 8 weeks 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 nonmelanomatous 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 8
weeks 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.
We found this trial at
2
sites
Buffalo, New York 14263
Principal Investigator: Todd Demmy, MD
Phone: 716-845-4427
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Keith Cengel, MD, PhD
Phone: 215-662-7720
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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