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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antineoplastic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014