Back to resultsCelecoxib Treatment for Lung Cancer
Primary Purpose
Non-Small-Cell Lung Carcinoma
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Celecoxib
Sponsored by
About this trial
This is an interventional basic science trial for Non-Small-Cell Lung Carcinoma focused on measuring cyclooxygenase 2, lung cancer, lymphocytes, non small cell, therapeutics
Eligibility 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
Sites / Locations
- VA Greater Los Angeles Healthcare System, West LA
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm 1
Arm Description
Celecoxib is an FDA approved drug for other indications such as osteoarthritis. It is not FDA approved for non-small cell lung cancer.
Outcomes
Primary Outcome Measures
Measure bio-markers; safety measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00108186
First Posted
April 14, 2005
Last Updated
October 28, 2014
Sponsor
US Department of Veterans Affairs
Collaborators
University of California, Los Angeles, City of Hope Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00108186
Brief Title
Celecoxib Treatment for Lung Cancer
Official Title
Celecoxib-Mediated Inhibition of T Regulatory Cells in Human Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Couldn't accrue patients
Study Start Date
October 2004 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
University of California, Los Angeles, City of Hope Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Carcinoma
Keywords
cyclooxygenase 2, lung cancer, lymphocytes, non small cell, therapeutics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Arm Description
Celecoxib is an FDA approved drug for other indications such as osteoarthritis. It is not FDA approved for non-small cell lung cancer.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure bio-markers; safety measures
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Dubinett, MD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West LA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West LA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
12. IPD Sharing Statement
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Celecoxib Treatment for Lung Cancer
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