Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-31 @ 11:32 PM
Study NCT ID:
NCT00100958
Status:
COMPLETED
Last Update Posted:
2008-07-24
First Post:
2005-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indole-3-Carbinol in Preventing Cancer in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C016517', 'term': 'indole-3-carbinol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-05', 'lastUpdateSubmitDate': '2008-07-23', 'studyFirstSubmitDate': '2005-01-07', 'studyFirstSubmitQcDate': '2005-01-07', 'lastUpdatePostDateStruct': {'date': '2008-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-01-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of indole-3-carbinol may prevent cancer.\n\nPURPOSE: This randomized phase I trial is studying the side effects and best dose of indole-3-carbinol and to see how well it works compared to placebo in preventing cancer in healthy participants.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose of indole-3-carbinol in healthy participants.\n* Determine the safety and tolerability of this drug in these participants.\n* Determine the pharmacokinetics of this drug in these participants.\n\nSecondary\n\n* Determine the effects of this drug on selected markers of sexual function in these participants.\n* Determine the effects of this drug on markers of susceptibility to cancer in these participants.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled, dose-escalation study. Participants at each dose level are randomized to 1 of 2 treatment arms.\n\n* Arm I: Participants receive a single dose of oral indole-3-carbinol on day 1.\n* Arm II: Participants receive a single dose of oral placebo on day 1. Cohorts of 3 participants receive escalating doses of indole-3-carbinol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity. An additional cohort of 3 participants is treated at the MTD.\n\nParticipants are followed on days 2, 3, and 6.\n\nPROJECTED ACCRUAL: A total of 24 participants (18 in arm I and 6 in arm II) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Healthy participants\n\n * Non-smoker\n * No drug abuse, as determined by urine cotinine and baseline drug screen\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 70\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* At least 12 months\n\nHematopoietic\n\n* Absolute granulocyte count \\> 1,500/mm\\^3\n* Hemoglobin \\> 10 g/dL\n\nHepatic\n\n* Bilirubin \\< 1.8 mg/dL\n* AST and ALT \\< 110 U/L\n* Alkaline phosphatase \\< 300 U/L\n\nRenal\n\n* Creatinine \\< 2.0 mg/dL\n* Albumin \\> 3.0 g/dL\n\nPulmonary\n\n* No asthma\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Weight within 20% of ideal body weight by the Metropolitan Life table\n* No serious drug allergies\n* No arthritis\n* No acute, unstable, chronic, or recurring medical condition\n* No strict vegetarians\n* No diabetes\n* No evidence of an active malignancy\n* No other serious intolerance or allergies\n\n * Mild seasonal allergies allowed\n* No other serious acute or chronic illness\n* None of the following chronic conditions:\n\n * Headaches\n * Dysphoria\n * Fatigue\n * Dizziness\n * Blurred vision\n * Insomnia\n * Rhinorrhea\n * Nausea\n * Vomiting\n * Abdominal pain\n * Diarrhea\n * Constipation\n * Premenstrual syndrome\n* Cessation of menses within the past 10 days (menstruating women only)\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior chemotherapy\n\nEndocrine therapy\n\n* Concurrent oral contraceptives allowed\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* More than 21 days since prior medications, herbal products, dietary supplements, or high-dose vitamins\n* More than 3 months since prior investigational drugs\n* At least 14 days since prior and no concurrent ingestion of cruciferous vegetables, including any of the following:\n\n * Broccoli\n * Cabbage, including coleslaw\n * Cauliflower\n * Bok-choy\n * Brussels sprouts\n * Collards\n * Kale\n * Kohlrabi\n * Mustard greens\n * Rutabaga\n * Turnip\n * Watercress\n* At least 7 days since prior and no concurrent alcohol consumption\n* At least 48 hours since prior ingestion of grapefruit-containing foods and beverages\n* No concurrent chronic drug therapy\n* No other concurrent supplements, including dietary supplements, vitamins, herbal products, or over-the-counter medications'}, 'identificationModule': {'nctId': 'NCT00100958', 'briefTitle': 'Indole-3-Carbinol in Preventing Cancer in Healthy Participants', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': "Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-Indolymethane (DIM) Nutritional Product", 'orgStudyIdInfo': {'id': 'CDR0000406002'}, 'secondaryIdInfos': [{'id': 'KUMC-HSC-9139-2'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'indole-3-carbinol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160-7357', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Gregory Reed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}