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.
|First Received Date||May 28, 2014|
|Last Changed Date||December 6, 2016|
|Start Date||May 2014|
|Anticipated Primary Completion Date||May 2018|
|Primary Outcome Measures||
Number of adverse events [Time Frame: 4 years]
|Study Arms / Comparison Groups||2 / 0|
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
Sally McNulty, RN
- 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.
- 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.
|Sponsor||Abramson Cancer Center of the University of Pennsylvania|
|Verification Date||December 2016|