Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT00784394
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2008-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diindolylmethane in Preventing Cancer in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C016392', 'term': "3,3'-diindolylmethane"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-28', 'studyFirstSubmitDate': '2008-11-01', 'studyFirstSubmitQcDate': '2008-11-01', 'lastUpdatePostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD), defined as the highest dose at which no grade 2 or higher toxicities are seen', 'timeFrame': 'Up to day 6', 'description': 'Frequencies and percents will be used to summarize the toxicities seen at each dose level and overall. Descriptive statistics will be calculated on all variables of interest: frequencies and percentages will be used to summarize categorical variables and medians, and ranges will summarize quantitative variables.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of diindolylmethane', 'timeFrame': 'Baseline and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after administration', 'description': 'Pharmacokinetic parameters such as half-life, maximum concentration (Cmax), time of Cmax (Tmax), and area under the concentration-time curve (AUC) will be calculated for all subjects who complete the study. It is anticipated that a one-compartment elimination model will fit the data. These parameters will be summarized at each dose and overall with median and ranges.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy, no Evidence of Disease']}, 'descriptionModule': {'briefSummary': 'This phase I clinical trial studies the side effects and best dose of diindolylmethane in preventing cancer in healthy volunteers. Diindolylmethane is formed in the stomachs of people who eat a chemical that is normally found in vegetables, including cabbage, broccoli, Brussels sprouts, cauliflower, and watercress. Diindolylmethane may prevent the development of cancer.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To determine single oral doses of 3,3' di-indolylmethane (DIM) (diindolylmethane) that are safe and well- tolerated.\n\nII. To determine the pharmacokinetics of these single oral doses of DIM.\n\nOUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 2 treatment arms.\n\nARM I: Participants receive a single dose of diindolylmethane orally (PO) on day 1.\n\nARM II: Participants receive a single dose of placebo orally (PO) on day 1.\n\nAfter completion of study treatment, participants are followed up on days 2, 3, and 6."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smokers and non-users of abuse drugs as confirmed by urine cotinine (Accutest NicoMeter Urine Professional strip or equivalent test) and drug screen at visit 1\n* Free of acute, unstable, chronic or recurring medical conditions based on history, physical examination, laboratory tests; the laboratory tests to be performed will be: blood serum chemistry screen to include comprehensive metabolic panel (glucose, creatinine, urea nitrogen \\[blood urea nitrogen (BUN)\\], sodium, potassium, chloride, calcium, total bilirubin, protein, albumin, globulin, cholesterol and the enzymes alkaline phosphatase, aspartate aminotransferase \\[AST\\], and alanine aminotransferase \\[ALT\\]) and lipid panel (total, low density lipoprotein \\[LDL\\] and high density lipoprotein \\[HDL\\] cholesterol and triglycerides); complete blood count including differential and platelet count; prothrombin time; and routine urinalysis; values for laboratory tests must be within the ranges below grade 2 of Common Toxicity Criteria (CTC) and/or as specified below:\n* Hemoglobin \\> 10 g/dL\n* Absolute granulocyte count \\> 1500/ìL\n* Creatinine \\< 2.0 mg/dl\n* Albumin \\> 3.0 g/dl\n* Bilirubin \\< 1.8 mg/dl\n* AST \\< 110 U/l\n* ALT \\< 110 U/l\n* Alkaline phosphatase \\< 300 U/l\n* Subjects must weigh +/- 20% of ideal body weight by the Metropolitan Life tables\n* Men or women who are strict vegetarians or who eat more than 3 medium servings (1/2 cup each) of cruciferous vegetables per week will be excluded; those who stop ingesting cruciferous vegetables \\>= 14 days and alcohol \\>= 7 days before starting DIM and agree to refrain from taking them for the duration of the study will not be excluded; cruciferous vegetables include broccoli, cabbage (including coleslaw), cauliflower, bok-choy, Brussels sprouts, collards, kale, kohlrabi, mustard greens, rutabaga, turnip, and watercress; participants will be asked to complete a brief diet questionnaire listing these vegetables to assess these criteria; caffeine- and grapefruit-containing foods and beverages are to be avoided for at least 48 hours before visit 2 (DIM dosing)\n\nExclusion Criteria:\n\n* Subjects with serious drug allergies or other serious intolerance or allergies will be excluded; those with mild seasonal allergies will be accepted\n* Subjects with chronic headaches, dysphoria, fatigue, dizziness, blurred vision, insomnia, rhinorrhea, nausea, vomiting, abdominal pain, diarrhea, constipation, or similar conditions\n* Subjects with a serious acute or chronic illness (diabetes, arthritis, asthma, etc.) or requiring chronic drug therapy, who continuously take supplements or have taken an investigational drug within the past three months\n* Subjects who have evidence of an active malignancy or have received chemotherapy, and/or antiestrogen therapy\n* Subjects who have a life expectancy of \\< 12 months\n* Subjects who have regularly taken over the past 21 days any concomitant medications, herbal products, dietary supplements or vitamins; women taking oral contraceptives will be accepted; women who are pregnant (positive urine human chorionic gonadotropin \\[hCG\\] at visit 2) or lactating will be excluded'}, 'identificationModule': {'nctId': 'NCT00784394', 'briefTitle': 'Diindolylmethane in Preventing Cancer in Healthy Volunteers', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': "Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-indolylmethane (DIM)", 'orgStudyIdInfo': {'id': 'NCI-2014-00523'}, 'secondaryIdInfos': [{'id': 'NCI-2014-00523', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'NO1-CN-35008-38'}, {'id': 'CDR0000617334'}, {'id': 'KUMC-HSC-9139', 'type': 'OTHER', 'domain': 'University of Kansas Medical Center'}, {'id': 'N01-CN-35008-1', 'type': 'OTHER', 'domain': 'DCP'}, {'id': 'N01CN35008', 'link': 'https://reporter.nih.gov/quickSearch/N01CN35008', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (diindolylmethane)', 'description': 'Participants receive a single dose of diindolylmethane PO on day 1.', 'interventionNames': ['Drug: diindolylmethane', 'Other: pharmacological study', 'Other: laboratory biomarker analysis', 'Other: quality-of-life assessment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II (placebo)', 'description': 'Participants receive a single dose of placebo orally (PO) on day 1.', 'interventionNames': ['Other: placebo', 'Other: pharmacological study', 'Other: laboratory biomarker analysis', 'Other: quality-of-life assessment']}], 'interventions': [{'name': 'diindolylmethane', 'type': 'DRUG', 'otherNames': ['DIM'], 'description': 'Given PO', 'armGroupLabels': ['Arm I (diindolylmethane)']}, {'name': 'placebo', 'type': 'OTHER', 'otherNames': ['PLCB'], 'description': 'Given PO', 'armGroupLabels': ['Arm II (placebo)']}, {'name': 'pharmacological study', 'type': 'OTHER', 'otherNames': ['pharmacological studies'], 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (diindolylmethane)', 'Arm II (placebo)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (diindolylmethane)', 'Arm II (placebo)']}, {'name': 'quality-of-life assessment', 'type': 'OTHER', 'otherNames': ['quality of life assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (diindolylmethane)', 'Arm II (placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Aryeh Hurwitz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}