Diindolylmethane in Preventing Cancer in Healthy Volunteers
Diindolylmethane in Preventing Cancer in Healthy Volunteers
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.
PRIMARY OBJECTIVES:

 I. To determine single oral doses of 3,3' di-indolylmethane (DIM) (diindolylmethane) that are
 safe and well- tolerated.

 II. To determine the pharmacokinetics of these single oral doses of DIM.

 OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 2 treatment
 arms.

 ARM I: Participants receive a single dose of diindolylmethane orally (PO) on day 1.

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

 After completion of study treatment, participants are followed up on days 2, 3, and 6.
Inclusion Criteria:

 -  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)

 Exclusion Criteria:

 -  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