Indole-3-Carbinol in Preventing Cancer in Healthy Participants

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00100958
First received: January 7, 2005
Last updated: July 23, 2008
Last verified: May 2006
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: indole-3-carbinol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-Indolymethane (DIM) Nutritional Product

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100958

Locations
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Gregory Reed, PhD University of Kansas
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00100958     History of Changes
Other Study ID Numbers: CDR0000406002, KUMC-HSC-9139-2
Study First Received: January 7, 2005
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Indole-3-carbinol
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014