Diindolylmethane in Preventing Cancer in Healthy Volunteers

NCT00784394 | Completed Phase 1

• 6 other identifiers: NCI-2014-00523NO1-CN-35008-38CDR0000617334KUMC-HSC-9139N01-CN-35008-1N01CN35008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy, no Evidence of Disease

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD), defined as the highest dose at which no grade 2 or higher toxicities are seen

  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.

  Up to day 6

Secondary Outcomes (1)

• Pharmacokinetics of diindolylmethane

  Baseline and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after administration

Study Arms (2)

Arm I (diindolylmethane)

EXPERIMENTAL

Participants receive a single dose of diindolylmethane PO on day 1.

Drug: diindolylmethane; Other: pharmacological study; Other: laboratory biomarker analysis; Other: quality-of-life assessment

Arm II (placebo)

PLACEBO COMPARATOR

Participants receive a single dose of placebo orally (PO) on day 1.

Other: placebo; Other: pharmacological study; Other: laboratory biomarker analysis; Other: quality-of-life assessment

Interventions

diindolylmethane DRUG

Given PO

Also known as: DIM

Arm I (diindolylmethane)

placebo OTHER

Given PO

Also known as: PLCB

Arm II (placebo)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I (diindolylmethane); Arm II (placebo)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (diindolylmethane); Arm II (placebo)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Arm I (diindolylmethane); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:
• Hemoglobin \> 10 g/dL
• Absolute granulocyte count \> 1500/ìL
• Creatinine \< 2.0 mg/dl
• Albumin \> 3.0 g/dl
• Bilirubin \< 1.8 mg/dl
• AST \< 110 U/l
• ALT \< 110 U/l
• Alkaline phosphatase \< 300 U/l
• Subjects must weigh +/- 20% of ideal body weight by the Metropolitan Life tables
• 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)

You may not qualify if:

• Subjects with serious drug allergies or other serious intolerance or allergies will be excluded; those with mild seasonal allergies will be accepted
• Subjects with chronic headaches, dysphoria, fatigue, dizziness, blurred vision, insomnia, rhinorrhea, nausea, vomiting, abdominal pain, diarrhea, constipation, or similar conditions
• 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
• Subjects who have evidence of an active malignancy or have received chemotherapy, and/or antiestrogen therapy
• Subjects who have a life expectancy of \< 12 months
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Interventions

3,3'-diindolylmethane

Study Officials

• Aryeh Hurwitz

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2008
• First Posted: November 4, 2008
• Study Start: April 1, 2004
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 29, 2016

Record last verified: 2016-12

Locations

US (1)