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 |
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.
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.
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
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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