Indole-3-Carbinol in Preventing Cancer in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-Indolymethane (DIM) Nutritional Product

Conditions
-----------------
Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Drug: indole-3-carbinol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: indole-3-carbinol|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified adult solid tumor, protocol specific