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MPM PDT Phase II Trial
Conditions
Epitheliod Malignant Pleural Mesothelioma
Conditions: official terms
Mesothelioma
Conditions: Keywords
Histological diagnosis of MPM, epitheliod subtype, limited to the hemithorax, macroscopically complete resection of the tumor
Study Type
Interventional
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Intervention
Name: Photodynamic Therapy
Type: Radiation
Name: Radical Pleurectomy
Type: Procedure
Name: Chemotherapy
Type: Radiation
Name: Photofrin 2.0 mg/kg
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
- 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.
Locations
Rosewell Park
Buffalo, New York, United States
Abramson Cancer Center of the University of Pennsylvania
Status: Recruiting
Contact: Michele Cooper, RN - 716-845-4427 - Michele.Cooper@RoswellPark.org
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Sally McNulty, RN - 215-662-7720 - Sally.McNulty@uphs.upenn.edu
Start Date
May 2014
Completion Date
May 2018
Sponsors
Abramson Cancer Center of the University of Pennsylvania
Source
Abramson Cancer Center of the University of Pennsylvania
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page