Photodynamic Therapy in Treating Patients With Resectable Non-Small Cell Lung Cancer That Has Spread to the Pleura
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|ClinicalTrials.gov Identifier: NCT00601848|
Recruitment Status : Terminated (Poor accrual and change in standards of care)
First Posted : January 28, 2008
Results First Posted : November 24, 2020
Last Update Posted : November 24, 2020
RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. Giving photodynamic therapy during surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy given during surgery works in treating patients with resectable non-small cell lung cancer that has spread to the pleura.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Metastatic Cancer||Drug: chemotherapy Drug: porfimer sodium Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: spectroscopy Procedure: therapeutic conventional surgery||Phase 2|
- To determine the overall survival rate of patients with non-small cell lung cancer (NSCLC) and malignant pleural spread treated with standard front-line chemotherapy followed by surgical resection and intra-operative porfimer sodium (Photofrin®)-mediated photodynamic therapy.
- To determine the feasibility and toxicities of standard front-line chemotherapy followed by surgical resection and intra-operative Photofrin®-mediated photodynamic therapy in these patients.
- To determine the progression-free survival and pleural progression-free survival of these patients.
- To determine the absolute Photofrin® levels in tumor and normal tissues resected from these patients using spectrofluorometric methods.
- To determine the tumor to normal tissue ratios of Photofrin® in these patients.
- To measure the optical properties of tumor and normal tissues in situ.
- To compare the Photofrin® concentration of tumor and normal tissues made with the in situ measurements to the measurements made with spectrofluorometric method.
OUTLINE: This is a multicenter study.
Patients receive 2-4 courses of standard front-line chemotherapy prior to surgery (if they have not completed the front-line chemotherapy).
Patients receive porfimer sodium (Photofrin®) IV over 5-15 minutes. Approximately 24 hours after receiving porfimer sodium, patients undergo surgery to remove the primary tumor and the pleural disease to a thickness of 5 mm or less*. Patients then undergo intraoperative photodynamic therapy to the residual disease. Some patients may undergo postoperative radiotherapy to the mediastinum and/or surgical scar if clinically indicated.
NOTE: *If the disease cannot be resected to less than 5 mm, PDT will not be delivered
Tumor and normal tissue samples are obtained from the surgical specimen and examined prior to light delivery at the time of thoracotomy, and after light delivery. Tissue samples are analyzed for porphyrin levels using a spectrofluorometric assay of tissue specimens and an in situ optical method intra-operatively. Samples are also assessed for V-cadherin, markers for oxidative stress, markers associated with photosensitizer uptake, markers for angiogenesis, markers for hypoxia, activation of signaling pathway components (including EGFR, p38 MAPK, Akt, and p42/44 MAPK) via immunohistochemistry.
After completion of study treatment, patients are followed periodically for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pleural Photodynamic Therapy for Patients With Non-small Cell Lung Cancer and Pleural Spread|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||December 2012|
Experimental: Photodynamic Therapy
Drug: porfimer sodium
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: therapeutic conventional surgery
- Toxicity Assessment of Pleural Photodynamic Therapy [ Time Frame: One year ]Toxicities of PDT as defined by CTCAE v4.0
- Overall Survival [ Time Frame: 5 years ]Subject survival post PDT
- Pleural Progression-free Survival [ Time Frame: 5 years ]Amount of time from PDT to disease progression in pleura
- Progression-free Survival [ Time Frame: 5 years ]Amount of time from PDT to disease progression at any site in the body
- Photofrin® Uptake [ Time Frame: 90 days ]Measured uptake of PDT drug
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601848
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Principal Investigator:||Keith Cengel, MD, PhD||Abramson Cancer Center of the University of Pennsylvania|