Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
A Pilot Study of Pleural Photodynamic Therapy for Patients With Pleural Malignancy
This pilot clinical trial studies photodynamic therapy during surgery in treating patients with pleural (the protective lining or membrane that covers the lungs and chest cavity) malignancy. Photodynamic therapy is an anti-cancer treatment that combines a photosensitizer (a substance that makes cells more sensitive to light), such as porfimer sodium, together with oxygen and visible light to kill tumor cells and/or damage the tumor's blood supply. Intraoperative (during surgery) photodynamic therapy may kill any tumor cells that remain after surgery.
PRIMARY OBJECTIVES; I. To determine the feasibility and toxicities of incorporating surgical
resection and intra-operative Photofrin (porfimer sodium)-mediated photodynamic therapy in
patients (pts) with malignant pleural mesothelioma (MPM) or non-small cell lung cancer
(NSCLC) with pleural spread.
SECONDARY OBJECTIVES:
I. To determine the overall survival rate of pts with NSCLC and pleural spread treated with
standard frontline chemotherapy followed by surgical resection and intra-operative
Photofrin-mediated photodynamic therapy.
II. To determine the overall survival rate of pts with MPM after radical pleurectomy and
intraoperative Photofrin-mediated photodynamic therapy (PDT).
III. To determine the progression-free survival and pleural progression-free survival in the
above mentioned pts.
IV. To determine the absolute Photofrin levels in tumor and normal tissues resected from pts
using spectrofluorometric assay. Photofrin levels in tumor to normal tissue ratios will be
determined.
OUTLINE:
Patients receive porfimer sodium intravenously (IV) over 3-5 minutes. Beginning 24 hours
later, patients undergo tumor resection and/or radical pleurectomy followed by intraoperative
PDT to the pleural space.
After completion of treatment, patients are followed up at 3, 6, 9, 12 and 24 months.
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