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Sponsors and Collaborators: |
University of California, Los Angeles Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00104767 |
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.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: celecoxib |
Phase I |
Study Type: | Interventional |
Study Design: | 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) |
Estimated Enrollment: | 24 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
PATIENT CHARACTERISTICS:
Other:
PRIOR CONCURRENT THERAPY:
Other:
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
Los Angeles, California, United States, 90095-1781 | |
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center 888-798-0719 |
Principal Investigator: | Edward Garon, MD | Jonsson Comprehensive Cancer Center |
Responsible Party: | UCLA Jonsson Comprehensive Cancer Center ( Edward Garon, MD ) |
Study ID Numbers: | CDR0000415733, UCLA-0407028-01 |
Study First Received: | March 3, 2005 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00104767 History of Changes |
Health Authority: | United States: Food and Drug Administration |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
Anti-Inflammatory Agents Thoracic Neoplasms Celecoxib Cyclooxygenase Inhibitors Cyclooxygenase 2 Inhibitors Recurrence Carcinoma Respiratory Tract Diseases Analgesics, Non-Narcotic |
Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase 2 Inhibitors Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Respiratory Tract Neoplasms Celecoxib |
Neoplasms by Histologic Type Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Carcinoma Neoplasms Analgesics, Non-Narcotic Lung Diseases Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |