Celecoxib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib in treating patients with stage IIIB or stage IV non-small cell lung cancer.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial to Evaluate Cyclooxygenase 2 Inhibitor-Mediated Modulation of T Regulatory Cells in Advanced Non-Small Cell Lung Cancer (NSCLC)|
- Optimal biologic dose (OBD) necessary to decrease peripheral blood lymphocyte (PBL) CD4+ and CD25+ T-lymphocyte regulatory cells at 1 week [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
- OBD necessary to decrease PBL FOXP3 levels at 1 week [ Time Frame: 7 dayd ] [ Designated as safety issue: No ]
- Function of CD4+ and CD25+ T-regulatory cells at 1 week [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Markers of cyclooxygenase-2 (COX-2) dependent gene expression before and after treatment at 1 week [ Time Frame: 7 days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
- 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 toxicity.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104767
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Edward Garon, MD||Jonsson Comprehensive Cancer Center|