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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00637 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (surgery, porfimer sodium, PDT) | Experimental | Patients receive porfimer sodium IV over 3-5 minutes. Beginning 24 hours later, patients undergo tumor resection and/or radical pleurectomy followed by intraoperative photodynamic therapy to the pleural space. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| porfimer sodium | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who received the entire multi-modality regimen | 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. | Up to 90 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 from study entry (start of chemotherapy) to death due to any cause or last patient contact, assessed up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meng Welliver | Ohio State University Comprehensive Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| therapeutic conventional surgery | Procedure | Undergo tumor resection and/or radical pleurectomy |
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| photodynamic therapy | Drug | Undergo PDT |
|
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| 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 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 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 | 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. | After surgery |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D017323 | Dihematoporphyrin Ether |
| D014307 | Trioxsalen |
| D010778 | Photochemotherapy |
| C008848 | 1-phenyl-3,3-dimethyltriazene |
| ID | Term |
|---|---|
| D017324 | Hematoporphyrin Derivative |
| D006415 | Hematoporphyrins |
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D011564 | Furocoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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