Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Non-Small Cell Lung Cancer And Bronchial Disease
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||Immunobiology of Photodynamic Therapy in Lung Cancer Patients|
- T cell mediated immune response measured by assays of tumor tissue, bronchoalveolar fluid, and plasma [ Designated as safety issue: No ]
- Survival rates at 6 months and 1 year [ Designated as safety issue: No ]
- Correlation between immune response and survival rates at 6 months and 1 year [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: Group 1
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
Active Comparator: Group 2
Patients undergo a baseline bronchoscopy and a repeat bronchoscopy at 4 weeks.
Patients undergo 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.
PROJECTED ACCRUAL: A total of 236 patients (177 undergoing photodynamic therapy [PDT] and 59 not undergoing PDT) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754910
|United States, Ohio|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210-1240|
|Principal Investigator:||Susan Moffatt-Bruce, MD, PhD||Ohio State University Comprehensive Cancer Center|