Indole-3-Carbinol in Preventing Cancer in Healthy Participants

July 23, 2008 updated by: University of Kansas

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Gregory Reed, PhD, University of Kansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Registration Dates

First Submitted

January 7, 2005

First Submitted That Met QC Criteria

January 7, 2005

First Posted (Estimate)

January 10, 2005

Study Record Updates

Last Update Posted (Estimate)

July 24, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000406002
  • KUMC-HSC-9139-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Unspecified Adult Solid Tumor, Protocol Specific

Clinical Trials on indole-3-carbinol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe