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MPM PDT Phase II Trial

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.

Tracking Information
First Received DateMay 28, 2014
Last Changed DateDecember 6, 2016
Start DateMay 2014
Anticipated Primary Completion DateMay 2018
Primary Outcome Measures

Number of adverse events [Time Frame: 4 years]

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Epitheliod Malignant Pleural Mesothelioma
Intervention
  • Radiation: Photodynamic Therapy
  • Procedure: Radical Pleurectomy
  • Radiation: Chemotherapy
  • Drug: Photofrin 2.0 mg/kg
Study Arms / Comparison Groups2 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment102
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Sally McNulty, RN
Email: Sally.Mcnulty@uphs.upenn.edu
Phone: 215-662-7720
Eligibility Criteria

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.

Administrative Information
NCTIDNCT02153229
Responsible Party,
SponsorAbramson Cancer Center of the University of Pennsylvania
Verification DateDecember 2016
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