- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00754910
Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Non-Small Cell Lung Cancer And Bronchial Disease
Immunobiology of Photodynamic Therapy in Lung Cancer Patients
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- To test the hypothesis that the immune response in non-small cell lung cancer patients treated with photodynamic therapy (PDT) is T cell mediated.
Secondary
- 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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ohio
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Columbus, Ohio, United States, 43210-1240
- Ohio State University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients that have a diagnosis of non-small cell lung cancer, of any stage, with obstructive or hemorrhagic endobronchial disease receiving PDT treatment.
Exclusion Criteria:
- Patients that have undergone PDT, chemotherapy or radiation therapy within the past 3 months will not be considered for enrollment.
- Patients taking antioxidant therapy will be excluded from enrollment due to potential interaction with the potential oxidative mechanism of action of Photofrin®. These antioxidants would include beta-carotene, lutein, Lycopene, Selenium, Vitamin A, Vitamin C, Vitamin E.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Given IV
Patients undergo bronchoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to one year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Susan Moffatt-Bruce, MD, PhD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-07115
- NCI-2011-03195 (Registry Identifier: Clinical Trials Reporting Program (CTRP))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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