Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT02348203
Status:
COMPLETED
Last Update Posted:
2022-06-02
First Post:
2015-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Clinical Study of the Effect of Combined Treatment of Aspirin and Zileuton on Biomarkers of Tobacco-Related Carcinogenesis in Current Smokers
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase II trial studies the effects of aspirin and zileuton on genes related to tobacco use in current smokers. Aspirin and zileuton may interfere with genes related to tobacco use and may be useful in preventing lung cancer in current smokers.
Detailed Description:
PRIMARY OBJECTIVES:
I. To analyze the impact of combined treatment of acetylsalicylic acid (ASA) (aspirin) and zileuton on smoking-related gene expression signature in the nasal epithelium in current smokers and to analyze any difference between the ASA and zileuton intervention and placebo control.
SECONDARY OBJECTIVES:
I. To assess the impact of ASA and zileuton on three lung cancer gene signatures (an 80-gene bronchial signature, a phosphatidylinositol 3-kinase \[PI3K\] pathway gene signature and a nasal diagnostic gene signature) and to compare this to placebo control.
II. To determine whether the change in the smoking-related gene expression signature and the three lung cancer gene signatures of nasal epithelium persists 10-14 days off agent intervention.
III. To measure urinary prostaglandin E metabolite (PGE-M) and leukotriene E(4) (LTE\[4\]) levels in current smokers after ASA and zileuton.
IV. To assess the safety in current smokers of 12 week exposure to ASA and zileuton.
V. To evaluate a gender effect in the modulatory effects of ASA and zileuton on smoking related-gene expression signature.
VI. To explore the effect of ASA and zileuton on the metabolomics profile of the arachidonic acid pathway.
VII. To explore, in a discovery-driven fashion, the effect of ASA and zileuton on whole-genome gene expression.
VIII. To analyze the impact of ASA and zileuton on karyometric analysis of buccal cells.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive aspirin orally (PO) once daily (QD) and zileuton PO twice daily (BID) for 12 weeks in the absence of unacceptable toxicity.
ARM II: Patients receive aspirin placebo PO QD and zileuton placebo PO BID for 12 weeks.
After completion of study treatment, patients are followed up for 2 weeks.
I. To analyze the impact of combined treatment of acetylsalicylic acid (ASA) (aspirin) and zileuton on smoking-related gene expression signature in the nasal epithelium in current smokers and to analyze any difference between the ASA and zileuton intervention and placebo control.
SECONDARY OBJECTIVES:
I. To assess the impact of ASA and zileuton on three lung cancer gene signatures (an 80-gene bronchial signature, a phosphatidylinositol 3-kinase \[PI3K\] pathway gene signature and a nasal diagnostic gene signature) and to compare this to placebo control.
II. To determine whether the change in the smoking-related gene expression signature and the three lung cancer gene signatures of nasal epithelium persists 10-14 days off agent intervention.
III. To measure urinary prostaglandin E metabolite (PGE-M) and leukotriene E(4) (LTE\[4\]) levels in current smokers after ASA and zileuton.
IV. To assess the safety in current smokers of 12 week exposure to ASA and zileuton.
V. To evaluate a gender effect in the modulatory effects of ASA and zileuton on smoking related-gene expression signature.
VI. To explore the effect of ASA and zileuton on the metabolomics profile of the arachidonic acid pathway.
VII. To explore, in a discovery-driven fashion, the effect of ASA and zileuton on whole-genome gene expression.
VIII. To analyze the impact of ASA and zileuton on karyometric analysis of buccal cells.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive aspirin orally (PO) once daily (QD) and zileuton PO twice daily (BID) for 12 weeks in the absence of unacceptable toxicity.
ARM II: Patients receive aspirin placebo PO QD and zileuton placebo PO BID for 12 weeks.
After completion of study treatment, patients are followed up for 2 weeks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2015-00061 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| N01-CN-2012-00031 | None | None | View | |
| 1403269898 | OTHER | Banner University Medical Center - Tucson | View | |
| UAZ2013-02-01 | OTHER | DCP | View | |
| N01CN00031 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA023074 | NIH | None | https://reporter.nih.gov/quic… | View |