This randomized phase II trial studies how well chemotherapy with or without porfimer sodium-based photodynamic therapy during surgery works in treating patients with malignant pleural mesothelioma. Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of cancer, either by killing the cancer cells, by stopping them from dividing, or by stopping them from spreading. Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. It is not yet known whether chemotherapy is more effective with or without porfimer sodium-based photodynamic therapy during surgery in treating patients with malignant pleural mesothelioma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02153229.
PRIMARY OBJECTIVES:
I. To test the superiority of overall survival (OS) in mesothelioma patients who undergo radical pleurectomy (RP) plus photodynamic therapy (PDT) relative to that of patients who undergo RP.
SECONDARY OBJECTIVES:
I. To determine whether the addition of PDT to surgery and postoperative chemotherapy improves progression free survival (PFS).
II. To assess serum for cytokine, tumor-associated antigen and anti-tumor antibody levels before and after surgery or surgery/PDT.
III. To evaluate molecular and microenvironment markers by immunohistochemical studies of excised tissue.
IV. To assess the contribution of toxicity from the photodynamic therapy. (For PDT subjects only)
V. To measure the uptake of Photofrin (porfimer sodium) in normal and malignant tissue. (For PDT subjects only)
VI. To evaluate activation of cytokine and growth factor signaling in tissue specimens obtained before, during and after surgery or surgery/PDT. (For PDT subjects only)
VII. To make non-invasive optical measurements of tumor and normal tissues, including optical properties, tissue oxygenation, photosensitizer uptake, and blood flow. (For PDT subjects only)
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive porfimer sodium intravenously (IV) over 5-15 minutes. Approximately 24 hours later, patients undergo RP with intraoperative PDT. Within 4-8 weeks after surgery, patients receive up to 4 courses of pemetrexed disodium with a platinum agent or other suitable regimen at the discretion of the study medical oncologist.
ARM II: Patients undergo RP. Within 4-8 weeks after surgery, patients receive pemetrexed disodium with a platinum agent or other suitable regimen at the discretion of the study medical oncologist as in Arm I.
After completion of study treatment, patients are followed up at 1 month, every 3 months for 24 months, and then every 3-6 months for up to 10 years.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorKeith A. Cengel
