Indole-3-Carbinol in Preventing Cancer in Healthy Participants

OBJECTIVES:

Primary

• Determine the maximum tolerated dose of indole-3-carbinol in healthy participants.
• Determine the safety and tolerability of this drug in these participants.
• Determine the pharmacokinetics of this drug in these participants.

Secondary

• Determine the effects of this drug on selected markers of sexual function in these participants.
• Determine the effects of this drug on markers of susceptibility to cancer in these participants.

OUTLINE: This is a randomized, double-blind, placebo-controlled, dose-escalation study. Participants at each dose level are randomized to 1 of 2 treatment arms.

• Arm I: Participants receive a single dose of oral indole-3-carbinol on day 1.
• 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.

Participants are followed on days 2, 3, and 6.

PROJECTED ACCRUAL: A total of 24 participants (18 in arm I and 6 in arm II) will be accrued for this study.

DISEASE CHARACTERISTICS:

• Healthy participants

• Non-smoker
• No drug abuse, as determined by urine cotinine and baseline drug screen

PATIENT CHARACTERISTICS:

Age

• 18 to 70

Performance status

• Not specified

Life expectancy

• At least 12 months

Hematopoietic

• Absolute granulocyte count > 1,500/mm^3
• Hemoglobin > 10 g/dL

Hepatic

• Bilirubin < 1.8 mg/dL
• AST and ALT < 110 U/L
• Alkaline phosphatase < 300 U/L

Renal

• Creatinine < 2.0 mg/dL
• Albumin > 3.0 g/dL

Pulmonary

• No asthma

Other

• Not pregnant or nursing
• Negative pregnancy test
• Weight within 20% of ideal body weight by the Metropolitan Life table
• No serious drug allergies
• No arthritis
• No acute, unstable, chronic, or recurring medical condition
• No strict vegetarians
• No diabetes
• No evidence of an active malignancy
• No other serious intolerance or allergies

• Mild seasonal allergies allowed
• No other serious acute or chronic illness
• None of the following chronic conditions:

• Headaches
• Dysphoria
• Fatigue
• Dizziness
• Blurred vision
• Insomnia
• Rhinorrhea
• Nausea
• Vomiting
• Abdominal pain
• Diarrhea
• Constipation
• Premenstrual syndrome
• Cessation of menses within the past 10 days (menstruating women only)

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Concurrent oral contraceptives allowed

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 21 days since prior medications, herbal products, dietary supplements, or high-dose vitamins
• More than 3 months since prior investigational drugs
• At least 14 days since prior and no concurrent ingestion of cruciferous vegetables, including any of the following:

• Broccoli
• Cabbage, including coleslaw
• Cauliflower
• Bok-choy
• Brussels sprouts
• Collards
• Kale
• Kohlrabi
• Mustard greens
• Rutabaga
• Turnip
• Watercress
• At least 7 days since prior and no concurrent alcohol consumption
• At least 48 hours since prior ingestion of grapefruit-containing foods and beverages
• No concurrent chronic drug therapy
• No other concurrent supplements, including dietary supplements, vitamins, herbal products, or over-the-counter medications