Evaluation of Apricoxib (Selective Cyclooxygenase 2 Inhibition) in Modulating T Regulatory Cells of Patients With Early Stage Non-small Cell Lung Cancer
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Compare level of CD4+CD25high T lymphocyte regulatory cells in peripheral blood lymphocytes and tumor infiltrating lymphocytes from surgical resection specimens of subjects with early stage NSCLC who have received apricoxib to those who have not
As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries. Peripheral blood and urine will be obtained on Days 0 and 7 from both groups (prior to surgical incision). Bronchoalveolar lavage (BAL) and lymph node tissue will be obtained on Days 0 and 7. TIL will be obtained from surgical resection specimens of the primary lung tumor only on Day 7
Jay M Lee, M.D.
University of California, Los Angeles
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center||Los Angeles, California 90095|