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Sponsors and Collaborators: |
University of Pennsylvania National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00601848 |
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 | Intervention | Phase |
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Lung Cancer Metastatic Cancer |
Drug: chemotherapy Drug: porfimer sodium Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: spectroscopy Procedure: therapeutic conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Pleural Photodynamic Therapy for Patients With Non-Small Cell Lung Cancer and Pleural Spread |
Estimated Enrollment: | 30 |
Study Start Date: | November 2004 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent chemotherapy or radiotherapy during the active study treatment period
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892 |
Principal Investigator: | Keith Cengel, MD, PhD | University of Pennsylvania |
Study ID Numbers: | CDR0000583050, UPCC-05503 |
Study First Received: | January 25, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00601848 History of Changes |
Health Authority: | Unspecified |
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer malignant pleural effusion |
Thoracic Neoplasms Pleural Effusion, Malignant Carcinoma Pleural Effusion Photosensitizing Agents Radiation-Sensitizing Agents Respiratory Tract Diseases Lung Neoplasms |
Dihematoporphyrin Ether Lung Diseases Neoplasm Metastasis Non-small Cell Lung Cancer Trioxsalen Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions Carcinoma Photosensitizing Agents Neoplasms Neoplastic Processes Pathologic Processes Neoplasms by Site |
Radiation-Sensitizing Agents Respiratory Tract Diseases Dihematoporphyrin Ether Lung Neoplasms Therapeutic Uses Lung Diseases Neoplasm Metastasis Trioxsalen Dermatologic Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |