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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Given IV
Undergo tumor resection and/or radical pleurectomy
Undergo PDT
Number of patients who received the entire multi-modality regimen
Time frame: Up to 2 years
Incidence of grade 4 or greater toxicity in the post-operative period as graded by the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects) version 4.0
All observed toxicities will be graded, tabled and summarized by frequencies and percentages.
Time frame: Up to 90 days post surgery
Overall survival
Estimated by the method of Kaplan and Meier. Overall survival will be estimated for all patients entered on trial, regardless of treatment received on-study or off-study.
Time frame: Time from study entry (start of chemotherapy) to death due to any cause or last patient contact, assessed up to 2 years
Progression-free survival (PFS)
Estimated by the method of Kaplan and Meier. PFS will be estimated for all patients entered on trial, regardless of treatment received on-study or off-study.
Time frame: Time from study entry to first documented progression (any type, intrapleural, distant, locoregional) or death due to any cause, assessed up to 2 years
Pleural progression-free survival (PPFS)
Estimated by the method of Kaplan and Meier. PPFS will be estimated for the subset of patients who receive PDT, in order to evaluate the impact of PDT on local control. Survival curves will be plotted. Median and 1-year estimates and confidence intervals will be calculated.
Time frame: Time from surgery/PDT to first documented intrapleural progression or death from any cause, assessed up to 2 years
Porfimer sodium uptake defined as the ratio of the porfimer sodium concentration in tumor tissue to normal tissue (i.e. skin) using spectrofluorometric assay
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Porfimer sodium concentration in the tissue will be calculated based on the increase in fluorescence resulting from the addition of a known amount of porfimer sodium to each sample after its initial reading. Absolute concentrations of porfimer sodium will also be measured. Distribution of uptake will be summarized by mean, median, standard deviation, range, and histogram. The tumor: normal tissue ratio from direct and indirect measurements will be calculated. Spearman's correlation will be employed to correlate and compare direct and indirect measurements.
Time frame: After surgery