NCT00104767

Celecoxib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

A Phase I Trial to Evaluate Cyclooxygenase 2 Inhibitor-Mediated Modulation of T Regulatory Cells in Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	celecoxib

Timeline

• Start date: 2009-01-01
• Primary completion: 2014-10-01
• Completion: 2015-10-01
• First posted: 2005-03-04
• Last updated: 2015-10-02

Locations

1 site across 1 country: United States