A Phase I Trial to Evaluate Cyclooxygenase 2 Inhibitor-Mediated Modulation of T Regulatory Cells in Advanced Non-Small Cell Lung Cancer (NSCLC)
- Determine the optimal biologic dose (OBD) of celecoxib that is necessary to decrease
peripheral blood lymphocyte CD4+ and CD25+ T-lymphocyte regulatory cells in patients
with stage IIIB or IV non-small cell lung cancer.
- Determine the OBD of this drug that is necessary to decrease peripheral blood
lymphocyte FOXP3 levels in these patients.
OUTLINE: This is a nonrandomized, dose-escalation study.
Patients receive oral celecoxib twice daily on days 1-7 in the absence of unacceptable
Cohorts of 3 patients receive escalating doses of celecoxib until the optimal biologic dose
(OBD) is determined. The OBD is defined as the lowest dose that results in the maximum
decrease in peripheral blood lymphocyte CD4+ and CD25+ T-lymphocyte regulatory cells and
FOXP3 levels where no dose-limiting toxicity occurs. An additional 15 patients are treated
at the OBD.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Optimal biologic dose (OBD) necessary to decrease peripheral blood lymphocyte (PBL) CD4+ and CD25+ T-lymphocyte regulatory cells at 1 week
Edward Garon, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|