Evaluation of Apricoxib (Selective Cyclooxygenase 2 Inhibition) in Modulating T Regulatory Cells of Patients With Early Stage Non-small Cell Lung Cancer
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 22, 2020 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Prevention
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Jonsson Comprehensive Cancer Center
- Interventions being studied
- Drug: Apricoxib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Jonsson Comprehensive Cancer CenterLos Angeles, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 22, 2020. Always confirm current availability with the study team.