Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT00056004
Status:
COMPLETED
Last Update Posted:
2013-04-29
First Post:
2003-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C063449', 'term': 'zileuton'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-25', 'studyFirstSubmitDate': '2003-03-06', 'studyFirstSubmitQcDate': '2003-03-06', 'lastUpdatePostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bronchial dysplasia number and grade at 6 months'}], 'secondaryOutcomes': [{'measure': 'Biomarkers (Ki-67, Cyclin D1, bcl-2, bax, caspase-3) by immunohistochemistry at 6 and 12 months'}, {'measure': 'Biomarkers (5-HETE, LTB-4) by blood and BAL levels at 6 and 12 months'}, {'measure': 'Adverse events as measured by number and severity monthly'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['non-small cell lung cancer', 'small cell lung cancer', 'stage I non-small cell lung cancer', 'stage I squamous cell carcinoma of the hypopharynx', 'stage I squamous cell carcinoma of the larynx', 'stage I squamous cell carcinoma of the lip and oral cavity', 'stage I squamous cell carcinoma of the nasopharynx', 'stage I squamous cell carcinoma of the oropharynx', 'stage II squamous cell carcinoma of the hypopharynx', 'stage II squamous cell carcinoma of the larynx', 'stage II squamous cell carcinoma of the lip and oral cavity', 'stage II squamous cell carcinoma of the nasopharynx', 'stage II squamous cell carcinoma of the oropharynx'], 'conditions': ['Head and Neck Cancer', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: Randomized phase II trial to study the effectiveness of zileuton in preventing lung cancer in patients who have bronchial dysplasia.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* 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.\n* Determine the overall toxicity of this drug in these patients.\n* Determine the 6-month natural history of bronchial dysplasia in patients who are randomized to receive treatment with a placebo.\n\nOUTLINE: 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.\n\n* Arm I: Patients receive oral zileuton 4 times daily for 6 months in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive oral placebo 4 times daily for 6 months in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed at 4 weeks.\n\nPROJECTED ACCRUAL: Approximately 134 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* At high risk for dysplasia, defined by 1 of the following criteria:\n\n * Current or former smokers who have smoked at least 30 pack-years\n\n * Former smokers must be enrolled within 20 years of complete smoking cessation\n * Patients with curatively treated stage I non-small cell lung cancer\\*\n * Patients with curatively treated stage I or II squamous cell carcinoma of the head and neck (limited to oral cavity, pharynx, or larynx)\\* NOTE: \\*At least 12 months post-curative therapy\n* Histologic confirmation of mild to severe bronchial dysplasia on bronchoscopic biopsy required\n\n * Moderate or severe atypia on sputum cytology required before bronchoscopy (not required for patients with prior lung or head and neck cancer)\n* No evidence of malignancy by chest x-ray\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over (for patients with prior lung or head and neck malignancy)\n* 35 and over (for all other patients)\n\nPerformance status\n\n* SWOG 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* WBC at least 3,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 10.0 g/dL\n* No bleeding disorder\n\nHepatic\n\n* Bilirubin no greater than upper limit of normal (ULN)\n* Liver enzymes no greater than ULN\n* PT/PTT no greater than ULN\n* No active or chronic liver disease (even if transaminases have normalized)\n\nRenal\n\n* Creatinine no greater than ULN\n\nCardiovascular\n\n* No unstable angina\n* No uncontrolled heart failure\n\nPulmonary\n\n* No significant asthma or chronic obstructive pulmonary disease requiring chronic or periodic (at least once per year) steroids for flares\n* No acute or chronic respiratory failure\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Willing and able to undergo serial bronchoscopic examinations\n* No ongoing alcohol use (i.e., at least 1 glass of wine, beer, or a mixed drink per day on a regular basis)\n* No other medical condition that would preclude safety during study participation\n* No other active or invasive malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix\n* No hypersensitivity to study drug or any of its inactive ingredients\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* More than 3 months since prior corticosteroids\\*\n* No concurrent corticosteroids\\*\n* No concurrent anticancer hormonal agents NOTE: \\*Systemic or inhaled, including chronic administration\n\nRadiotherapy\n\n* No concurrent radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* More than 3 months since prior lipoxygenase inhibitors\\*\n* More than 3 months since prior investigational agents\n* More than 3 months since prior nutritional supplements (except 1 daily multivitamin)\n* No concurrent nutritional supplements (except 1 daily multivitamin)\n* No other concurrent lipoxygenase inhibitors\\*\n* No other concurrent investigational agents\n* No concurrent warfarin, beta-blockers, or theophylline\n* No other concurrent antineoplastic agents\n* No concurrent or chronic daily use of non-steroidal anti-inflammatory agents (NSAIDS) (except cardioprotective doses of aspirin less than 100 mg/day)\n\n * Periodic use of NSAIDS allowed\n* Concurrent participation in a smoking cessation program (including use of bupropion or nicotine gum or patch) allowed NOTE: \\*Systemic or inhaled, including chronic administration'}, 'identificationModule': {'nctId': 'NCT00056004', 'briefTitle': 'Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia', 'organization': {'class': 'OTHER', 'fullName': 'Barbara Ann Karmanos Cancer Institute'}, 'officialTitle': 'Phase II Trial Of Zileuton In Persons With Bronchial Dysplasia', 'orgStudyIdInfo': {'id': 'CDR0000271915'}, 'secondaryIdInfos': [{'id': 'P30CA022453', 'link': 'https://reporter.nih.gov/quickSearch/P30CA022453', 'type': 'NIH'}, {'id': 'WSU-D-2405'}, {'id': 'WSU-093201MP4F'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'zileuton', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48201-1379', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Omer Kucuk, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Barbara Ann Karmanos Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barbara Ann Karmanos Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}