- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01532362
Evaluation of Apricoxib (Selective Cyclooxygenase 2 Inhibition) in Modulating T Regulatory Cells of Patients With Early Stage Non-small Cell Lung Cancer
September 21, 2020 updated by: Jonsson Comprehensive Cancer Center
The primary objective for this trial is to determine the biological ability of apricoxib to decrease T reg cells in the peripheral blood and tumor infiltrating lymphocytes in subjects compared to those who have not in subjects with early stage Non-small Cell Lung Cancer (NSCLC).
The secondary objectives are to determine the efficacy of apricoxib to inhibit CD4+CD25+ T reg and FOXP3 function and exploration of COX-2 dependent biomarkers of apoptosis resistance, angiogenesis, invasion, and immunity.
Study Overview
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095
- Jonsson Comprehensive Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults over the age of 18 capable of giving informed consent. Radiographic findings suspicious for primary lung cancer or pathologically confirmed NSCLC which is surgically resectable and radiographically early stage (stage I and II).
- ECOG performance status of 0, 1, or 2 (see Appendix A).
- Ineligible for or refuse preoperative chemotherapy or chemoradiation therapy
- Normal renal function (defined as serum creatinine ≤ 2 mg/dl or creatinine clearance ≥ 60 ml/min/1.73m2).
- Normal liver function (defined as total bilirubin ≤ 1.5 x ULN, SGOT & SGPT ≤ 2.5 xULN).
- Negative pregnancy test prior to initiation of treatment and adequate contraception throughout treatment.
- Preoperative pulmonary function test (PFT) with FEV1 and D LCO ≥ 60% or predicted postoperative FEV1 and DLCO ≥ 40% based on quantitative lung perfusion scan
- Must be able to come off anticoagulants and have normal coagulation studies (PTT < 40 seconds and INR < 1.4) prior to planned surgery.
- For subjects on COX-2 inhibitors or other NSAIDS prior to study initiation, cessation of the drug for 1 week prior to Apricoxib administration is required for study enrollment.
Exclusion Criteria:
- Radiation therapy, chemotherapy, non-cytotoxic investigational agents, or corticosteroids within 4 weeks of initiating treatment.
- Comorbid disease or a medical condition that would impair the ability of the subject to receive or comply with the study protocol.
- Hypersensitivity to apricoxib, sulfonamides, aspirin, or other NSAIDS or to any reagents used in the study.
- Previous history of gastrointestinal ulceration, bleeding, or perforation.
- Required concurrent use of COX-2 inhibitors or other NSAIDS during Apricoxib administration.
- Chronic or concurrent use of steroids (topical steroids are acceptable if medically indicated).
- Pregnant or nursing women.
- Evidence of NYHA class III or greater cardiac disease.
- History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months of initiating treatment.
- History of heart surgery for coronary artery disease.
- Known HIV infection or AIDS.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Apricoxib
As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
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As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
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Other: No drug intervention
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As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare Level of CD4+CD25high T Lymphocyte Regulatory Cells in Peripheral Blood Lymphocytes and Tumor Infiltrating Lymphocytes From Surgical Resection Specimens of Subjects With Early Stage NSCLC Who Have Received Apricoxib to Those Who Have Not
Time Frame: 7 days
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As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
Peripheral blood and urine will be obtained on Days 0 and 7 from both groups (prior to surgical incision).
Bronchoalveolar lavage (BAL) and lymph node tissue will be obtained on Days 0 and 7. TIL will be obtained from surgical resection specimens of the primary lung tumor only on Day 7
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7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of Apricoxib on Levels of CD4+CD25+ T Regulatory Cells in Peripheral Blood.Also,Biomarkers of Apoptosis Resistance,Angiogenesis,Invasion and Immunity Will be Tested in the Lab to Check How Effective Apricoxib is in Inhibiting These Proteins.
Time Frame: 7 days
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Peripheral blood from patients with NSCLC has been reported to have an increase in the percentages of CD4+CD25+ T reg cells.In contrast <10% of the PBLs of normal donors have this phenotype.
As such, CD4+CD25+ cells will be assessed in addition to FOXP3 levels in PBL.
In addition, exploration of COX-2 dependent biomarkers of apoptosis resistance, angiogenesis, invasion, and immunity will be studied.
COX-2, FOXP3, IL-10, IL-12, MDC, CXCR4 and survivin will be analyzed in plasma.
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7 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jay M Lee, M.D., University of California, Los Angeles
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
November 30, 2011
First Submitted That Met QC Criteria
February 9, 2012
First Posted (Estimate)
February 14, 2012
Study Record Updates
Last Update Posted (Actual)
September 22, 2020
Last Update Submitted That Met QC Criteria
September 21, 2020
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-002081
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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