Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
Study NCT ID:
NCT00006457
Status:
COMPLETED
Last Update Posted:
2012-06-11
First Post:
2000-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oltipraz in the Prevention of Lung Cancer in People Who Smoke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C026209', 'term': 'oltipraz'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-07', 'studyFirstSubmitDate': '2000-11-06', 'studyFirstSubmitQcDate': '2003-05-29', 'lastUpdatePostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['non-small cell lung cancer', 'small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer.\n\nPURPOSE: Randomized phase I trial to study the effectiveness of oltipraz in preventing lung cancer in people who smoke.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the effect of oltipraz on the level of BP-7,8-diol-9,10-epoxide (BPDE) DNA adducts in the lung lining cells (macrophages and bronchial epithelial cells) of smokers.\n* Determine the tolerability and toxicity of this treatment regimen in these patients.\n* Determine the effect of this treatment regimen on the level of macromolecule adducts in the blood (e.g., BPDE DNA, BPDE hemoglobin, and 8-hydroxy-deoxyguanine), oral lining cells (BPDE DNA), bladder lining cells (4-aminobiphenyl DNA), and lung macrophages (8-hydroxy-deoxyguanine) in these patients.\n* Determine the effect of this treatment regimen on the change (decrease) in activation of NNK as measured by change (increase) in urinary NNAL plus NNAL glucuronide in these patients.\n* Determine the effect of this treatment regimen on the oxidative state, glutathione-S-transferase activity, and superoxide dismutase 3 and phase II enzymes in the lungs and blood of these patients.\n* Compare the changes in oxidative state and phase II enzymes with changes in adduct levels in the lungs and blood of these patients.\n* Determine the correlation between oltipraz-induced changes in phase II enzymes and adduct formation with genotypic variation in glutathione-S-transferase isozymes in these patients.\n* Compare the response to this treatment regimen in terms of oxidative state, phase II enzymes, and adduct formation in the lungs vs the blood in these patients.\n\nOUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of three treatment arms.\n\n* Arm I: Patients receive an oral placebo weekly.\n* Arm II: Patients receive low-dose oral oltipraz weekly.\n* Arm III: Patients receive high-dose oral oltipraz weekly. Treatment continues for 12 weeks in the absence of unacceptable toxicity.\n\nPatients are followed at 4 weeks.\n\nPROJECTED ACCRUAL: A total of 66 patients (22 per treatment arm) will be accrued for this study within 21 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Current cigarette smokers\n\n * At least 20 cigarettes a day\n * No variation of more than 10 in the number of cigarettes smoked per day within the past 3 months\n * At least 10 years of smoking any amount\n * Failed to stop smoking after at least one attempt to quit within the last 3 years\n* Prior stage I non-small cell lung cancer allowed if surgically resected with at least a lobectomy\n* No concurrent evidence of lung cancer\n* Willing to undergo 2 bronchoscopies\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* CBC normal\n* Hemostasis normal\n\nHepatic:\n\n* PT and PTT normal\n\nRenal:\n\n* Blood chemistries normal\n* Nonfasting glucose no greater than 200 mg/dL\n* No active renal disease\n* No urinary tract infection by urinalysis (trace protein allowed)\n\nCardiovascular:\n\n* EKG normal\n* No coronary artery disease requiring continuous medication\n\nPulmonary:\n\n* Chest radiograph normal (postsurgical changes allowed)\n* No acute or significant chronic abnormality\n* FEV1 greater than 1.8 L or 75% predicted\n* No chronic obstructive pulmonary disease requiring continuous medication\n\nOther:\n\n* No known hypersensitivity or prior adverse reaction to oltipraz\n* No inmates or prisoners\n* No medical or psychological condition that would preclude study (e.g., acute psychosis)\n* No prior malignancy except nonmelanomatous skin cancer, cervical dysplasia, or curatively treated stage I or II cancer of the head and neck\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 6 months after study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* At least 3 months since prior potential chemoprevention agent (e.g., oltipraz, retinoids, or acetylcysteine)\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00006457', 'briefTitle': 'Oltipraz in the Prevention of Lung Cancer in People Who Smoke', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Clinical Phase I Multiple-Dose Safety Research Study of Oltipraz in Smokers', 'orgStudyIdInfo': {'id': 'NCI 00L1'}, 'secondaryIdInfos': [{'id': 'NU-00L1'}, {'id': 'DUMC-000346-00-2'}, {'id': 'NCI-P00-0167'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'oltipraz', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611-3013', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Raymond C. Bergan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Robert H. Lurie Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}