Lung Cancer
Conditions
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
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.
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.
Interventions
DRUGporfimer sodium
Given IV
PROCEDUREbronchoscopy
Patients undergo bronchoscopy
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the cytokine phenotype found in collected specimens of lung cancer patients treated with photodynamic therapy. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlate the cytokine phenotype of patients undergoing PDT treatment with survival | 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. |
Countries
United States
Outcome results
None listed