Lung Cancer Clinical Trial
Official title:
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.
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.
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