Clinical trial NCT00754910: Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Non-Small Cell Lung Cancer And Bronchial Disease
Official title: Immunobiology of Photodynamic Therapy in Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
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
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2008-09-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: lung cancer patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the cytokine phenotype found in collected specimens of lung cancer patients treated with photodynamic therapy.
timeFrame: up to one year
Secondary outcomes:
measure: Correlate the cytokine phenotype of patients undergoing PDT treatment with survival
timeFrame: up to one year
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Susan Moffatt-Bruce, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: