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
2 other identifiers
observational
35
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2008
CompletedFirst Posted
Study publicly available on registry
September 18, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJuly 5, 2018
July 1, 2018
7.3 years
September 17, 2008
July 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the cytokine phenotype found in collected specimens of lung cancer patients treated with photodynamic therapy.
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 Outcomes (1)
Correlate the cytokine phenotype of patients undergoing PDT treatment with survival
up to one year
Study Arms (1)
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.
Interventions
Eligibility Criteria
lung cancer patients
You may qualify if:
- Patients that have a diagnosis of non-small cell lung cancer, of any stage, with obstructive or hemorrhagic endobronchial disease receiving PDT treatment.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Medical Center
Columbus, Ohio, 43210-1240, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Moffatt-Bruce, MD, PhD
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 17, 2008
First Posted
September 18, 2008
Study Start
December 1, 2008
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
July 5, 2018
Record last verified: 2018-07