Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Non-Small Cell Lung Cancer And Bronchial Disease
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|ClinicalTrials.gov Identifier: NCT00754910|
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : July 5, 2018
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against non-small cell lung cancer.
PURPOSE: This clinical trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with non-small cell lung cancer and bronchial disease.
|Condition or disease||Intervention/treatment|
|Lung Cancer||Drug: porfimer sodium Procedure: bronchoscopy|
- To test the hypothesis that the immune response in non-small cell lung cancer patients treated with photodynamic therapy (PDT) is T cell mediated.
- To test the hypothesis that PDT potentially affects survival rates in these patients.
- To test the hypothesis that T lymphocytes mediate an immune response that affects survival in PDT treated patients.
OUTLINE: Patients deemed suitable for photodynamic therapy (PDT) are offered PDT. Patients are divided into 2 groups according to whether or not they receive PDT. All patients are referred to radiation and medical oncology for standard of care adjuvant therapy (beginning after completion of this study).
- Group 1 (PDT): Patients receive porfimer sodium IV over 3-5 minutes and undergo irradiation with red light 48 hours later. Patients receive 2 more treatments at 2-day intervals.
- Group 2 (non-PDT): Patients undergo a baseline bronchoscopy and a repeat bronchoscopy at 4 weeks.
Blood sample, bronchoalveolar lavage fluid, and tumor tissue are collected after each treatment (group 1) or at time of each bronchoscopy (group 2) and assayed for the presence of lymphocyte phenotypes Th1, Th2, Treg, and Th17. After completion of study therapy, patients are followed at 1 month after PDT and then every 3 months for 3 years.
|Study Type :||Observational|
|Actual Enrollment :||35 participants|
|Official Title:||Immunobiology of Photodynamic Therapy in Lung Cancer Patients|
|Actual Study Start Date :||December 2008|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Patients receive porfimer sodium IV over 3-5 minutes and undergo irradiation with red light 48 hours later. Patients receive 2 more treatments at 2-day intervals.
Drug: porfimer sodium
Patients undergo bronchoscopy
- Determine the cytokine phenotype found in collected specimens of lung cancer patients treated with photodynamic therapy. [ Time Frame: up to one year ]Tumor tissue, broncheoalveolar fluid and blood from enrolled patients will be assayed for the presence of the following defined lymphocyte phenotypes
- Correlate the cytokine phenotype of patients undergoing PDT treatment with survival [ Time Frame: up to one year ]The immune response that is established will be statistically correlated with the survival rate measured at 6 months and 1 year. This will allow us to discern if a higher survival rate is associated with a specific immune response.
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): NCT00754910
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210-1240|
|Principal Investigator:||Susan Moffatt-Bruce, MD, PhD||Ohio State University Comprehensive Cancer Center|