Indole-3-Carbinol in Preventing Cancer in Healthy Participants

University of Kansas

Overview

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of indole-3-carbinol may prevent cancer. PURPOSE: This randomized phase I trial is studying the side effects and best dose of indole-3-carbinol and to see how well it works compared to placebo 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

indole-3-carbinolDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, United States

Data from ClinicalTrials.gov

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