|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00056004 |
Purpose
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.
| Condition | Intervention | Phase |
|
Head and Neck Cancer Lung Cancer |
Drug: zileuton |
Phase II |
| MedlinePlus related topics: | Cancer Head and Neck Cancer Lung Cancer |
| ChemIDplus related topics: | Zileuton |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
| Official Title: | Phase II Trial Of Zileuton In Persons With Bronchial Dysplasia |
| Estimated Enrollment: | 134 |
| Study Start Date: | September 2002 |
OBJECTIVES:
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.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: Approximately 134 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At high risk for dysplasia, defined by 1 of the following criteria:
Current or former smokers who have smoked at least 30 pack-years
Histologic confirmation of mild to severe bronchial dysplasia on bronchoscopic biopsy required
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent or chronic daily use of non-steroidal anti-inflammatory agents (NSAIDS) (except cardioprotective doses of aspirin less than 100 mg/day)
Contacts and Locations| United States, Michigan | |||||
| Barbara Ann Karmanos Cancer Institute | |||||
| Detroit, Michigan, United States, 48201-1379 | |||||
| Barbara Ann Karmanos Cancer Institute |
| National Cancer Institute (NCI) |
| Study Chair: | Omer Kucuk, MD | Barbara Ann Karmanos Cancer Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Featured trial article 
  |
| Study ID Numbers: | CDR0000271915, WSU-D-2405, WSU-093201MP4F |
| First Received: | March 6, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00056004 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|
|