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
| Tracking Information | |||||
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| First Received Date ICMJE | April 14, 2005 | ||||
| Last Updated Date | August 10, 2011 | ||||
| Start Date ICMJE | October 2004 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Measure bio-markers; safety measures [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00108186 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Celecoxib Treatment for Lung Cancer | ||||
| Official Title ICMJE | Celecoxib-Mediated Inhibition of T Regulatory Cells in Human Lung Cancer | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Non-Small-Cell Lung Carcinoma | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) | 1
Celecoxib is an FDA approved drug for other indications such as osteoarthritis. It is not FDA approved for non-small cell lung cancer.
Intervention: Drug: Celecoxib |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 24 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Hypersensitivity to celecoxih or NSAIDs, previous history of GI bleeding or ulceration, chronic or concurrent use of steroids and renal insufficiency |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00108186 | ||||
| Other Study ID Numbers ICMJE | ONCA-043-04S | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dubinett, Steven - Principal Investigator, Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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