Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056004
Status:
COMPLETED
Last Update Posted:
2013-04-29
First Post:
2003-03-06
Brief Title:
Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase II Trial Of Zileuton In Persons With Bronchial Dysplasia
Status:
COMPLETED
Status Verified Date:
2013-04
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:
RATIONALE Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer The use of zileuton may be an effective way to prevent lung cancer in patients who have bronchial dysplasia
PURPOSE Randomized phase II trial to study the effectiveness of zileuton in preventing lung cancer in patients who have bronchial dysplasia
PURPOSE Randomized phase II trial to study the effectiveness of zileuton in preventing lung cancer in patients who have bronchial dysplasia
Detailed Description:
OBJECTIVES
Determine the efficacy of zileuton in terms of number of sites and grade of dysplastic lesions in the bronchial epithelium in patients with documented bronchial dysplasia
Correlate the regression of bronchial dysplasia number and grade and improvement in sputum cytology with the modulation of molecular biomarkers in patients treated with this drug
Determine the overall toxicity of this drug in these patients
Determine the 6-month natural history of bronchial dysplasia in patients who are randomized to receive treatment with a placebo
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to smoking status current vs recently quit smoker and prior cancer none vs lung or head and neck Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral zileuton 4 times daily for 6 months in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral placebo 4 times daily for 6 months in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL Approximately 134 patients will be accrued for this study
Determine the efficacy of zileuton in terms of number of sites and grade of dysplastic lesions in the bronchial epithelium in patients with documented bronchial dysplasia
Correlate the regression of bronchial dysplasia number and grade and improvement in sputum cytology with the modulation of molecular biomarkers in patients treated with this drug
Determine the overall toxicity of this drug in these patients
Determine the 6-month natural history of bronchial dysplasia in patients who are randomized to receive treatment with a placebo
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to smoking status current vs recently quit smoker and prior cancer none vs lung or head and neck Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral zileuton 4 times daily for 6 months in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral placebo 4 times daily for 6 months in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL Approximately 134 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WSU-093201MP4F | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |
| WSU-D-2405 | None | None | None |