Celecoxib Treatment for Lung Cancer
This study has been terminated.
(Couldn't accrue patients at the VA and study terminated at the VA but open at UCLA and City of Hope Medical centers. Termination date at the VA is 8/9/2011)
Sponsor:
Collaborators:
University of California, Los Angeles
City of Hope Medical Center
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108186
First received: April 14, 2005
Last updated: August 10, 2011
Last verified: August 2011
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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 ]
| Estimated Enrollment: | 24 |
| 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 |
|---|---|
|
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 celecoxih or NSAIDs, previous history of GI bleeding or ulceration, chronic or concurrent use of steroids and renal insufficiency
Contacts and Locations
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: | Dubinett, Steven - Principal Investigator, 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: | August 10, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
cyclooxygenase 2 lung cancer lymphocytes non small cell theraputics |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Celecoxib Cyclooxygenase 2 Inhibitors |
Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013