Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Celecoxib Treatment for Lung Cancer

This study has been withdrawn prior to enrollment.
(Couldn't accrue patients)
Sponsor:
Collaborators:
University of California, Los Angeles
City of Hope Medical Center
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108186
First received: April 14, 2005
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

This proposal evaluates cyclooxygenase 2 (COX-2) inhibition as a means to decrease T regulatory cell activities and thus augment immune responses against lung cancer. The broad goal focuses on understanding how COX-2 expression regulates the malignant phenotype in non small cell lung cancer in an effort to foster an informed approach for the use of COX-2 inhibitors in prevention and therapy for lung cancer.


Condition Intervention Phase
Non-Small-Cell Lung Carcinoma
Drug: Celecoxib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Celecoxib-Mediated Inhibition of T Regulatory Cells in Human Lung Cancer

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Measure bio-markers; safety measures [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2004
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Celecoxib is an FDA approved drug for other indications such as osteoarthritis. It is not FDA approved for non-small cell lung cancer.
Drug: Celecoxib
Eight subjects will be assigned to one of three cohorts. Subjects will receive Celecoxib in escalating doses per cohort, starting with 200mg twice a day by mouth; 400mg twice a day by mouth; and increasing to 600mg twice a day by mouth, for a total of 7 days. Subjects will have blood taken before the start of Celecoxib, and after completion of 7-days of Celecoxib.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed and surgically resectable non small cell lung cancer and subjects must be ineligible for or refuse, neoadjuvant therapy

Exclusion Criteria:

Hypersensitivity to celecoxib or NSAIDs, previous history of GI bleeding or ulceration, chronic or concurrent use of steroids and renal insufficiency

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108186

Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
University of California, Los Angeles
City of Hope Medical Center
Investigators
Principal Investigator: Steven Dubinett, MD VA Greater Los Angeles Healthcare System, West LA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108186     History of Changes
Other Study ID Numbers: ONCA-043-04S
Study First Received: April 14, 2005
Last Updated: October 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
cyclooxygenase 2
lung cancer
lymphocytes
non small cell
therapeutics

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Celecoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014