Diindolylmethane in Healthy Volunteers

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase I trial is studying the side effects and best dose of diindolylmethane in healthy volunteers. Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of diindolylmethane may keep cancer from forming. Collecting and storing samples of blood and urine from healthy volunteers to study in the laboratory may help doctors learn more about the way a person's body handles the drug.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: 3,3'-diindolylmethane

Criteria

Criteria:

• Healthy men and women

• Nonsmoker confirmed by urine cotinine test

• No active malignancy

• Life expectancy >= 12 months

• Hemoglobin > 10 g/dL

• Absolute granulocyte count > 1,500/mm^3

• Creatinine < 2.0 mg/dL

• Albumin > 3.0 g/dL

• Bilirubin < 1.8 mg/dL

• AST and ALT < 110 U/L

• Alkaline phosphatase < 300 U/L

• Body mass index =< 30

• Not pregnant or nursing

• Negative pregnancy test

• Fertile participants must use effective nonhormonal contraception

• No acute, unstable, chronic, or recurring medical conditions

• No strict vegetarians or consumption of > 3 medium servings (1/2 cup each) of cruciferous vegetables per week

• Participants who have stopped eating cruciferous vegetables within the past 2 weeks and agree to refrain from eating them for the duration of the study are eligible

• Cruciferous vegetables include broccoli, cabbage (including coleslaw), cauliflower, bok-choy, brussels sprouts, collards, kale, kohlrabi, mustard greens, rutabaga, turnip, and watercress

• No serious drug allergies or other serious intolerance or allergies

• Mild seasonal allergies allowed

• No chronic conditions, including headaches, dysphoria, fatigue, dizziness, blurred vision, insomnia, rhinorrhea, nausea, vomiting, abdominal pain, diarrhea, constipation, menopausal hot flashes/night sweats, or clinically significant premenstrual syndrome

• No serious acute or chronic illness

• No requirement for chronic drug therapy

• No alcohol ingestion within 48 hours of study treatment

• No investigational drugs within the past 3 months

• No prior chemotherapy

• No concurrent regular medications or hormones

• No recent change in medications or dosage of medications

• No concurrent regular supplements or vitamins

• No concurrent over-the-counter medications

• No concurrent grapefruit or its juice