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Evaluation of Apricoxib (Selective Cyclooxygenase 2 Inhibition) in Modulating T Regulatory Cells of Patients With Early Stage Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

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Evaluation of Apricoxib (Selective Cyclooxygenase 2 Inhibition) in Modulating T Regulatory Cells of Patients With Early Stage Non-small Cell Lung Cancer

NCT01532362•Jonsson Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (1)

Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Key Dates

Start Date

November 1, 2011

Primary Completion Date

May 1, 2012

Completion Date

May 1, 2012

Last Updated

September 22, 2020

Enrollment

ACTUAL participants

Conditions

Non Small Cell Lung Cancer

Interventions

Apricoxib

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluation of Apricoxib (Selective Cyclooxygenase 2 Inhibition) in Modulating T Regulatory Cells of Patients With Early Stage Non-small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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