Back to resultsEvaluation of Apricoxib (Selective Cyclooxygenase 2 Inhibition) in Modulating T Regulatory Cells of Patients With Early Stage Non-small Cell Lung Cancer
Primary Purpose
Non Small Cell Lung Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apricoxib
Sponsored by
About this trial
This is an interventional prevention trial for Non Small Cell Lung Cancer
Eligibility Criteria
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.
Sites / Locations
- Jonsson Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Apricoxib
No drug intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01532362
First Posted
November 30, 2011
Last Updated
September 21, 2020
Sponsor
Jonsson Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01532362
Brief Title
Evaluation of Apricoxib (Selective Cyclooxygenase 2 Inhibition) in Modulating T Regulatory Cells of Patients With Early Stage Non-small Cell Lung Cancer
Official Title
Evaluation of Apricoxib (Selective Cyclooxygenase 2 Inhibition) in Modulating T Regulatory Cells of Patients With Early Stage Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
Drug sponsor stopped drug manufacture due to toxicity issues from other studies
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apricoxib
Arm Type
Experimental
Arm Description
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.
Arm Title
No drug intervention
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Apricoxib
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
7 days
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay M Lee, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Apricoxib (Selective Cyclooxygenase 2 Inhibition) in Modulating T Regulatory Cells of Patients With Early Stage Non-small Cell Lung Cancer
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