Indole-3-Carbinol in Preventing Cancer in Healthy Participants

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: Unspecified Adult Solid Tumor, Protocol Specific
• Intervention / Treatment: Drug: indole-3-carbinol

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

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

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 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

How is the study designed?

Design Details

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

Collaborators and Investigators

• Sponsor: University of Kansas
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Gregory Reed, PhD, University of Kansas

Study record dates

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: unspecified adult solid tumor, protocol specific
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Protective Agents; Anticarcinogenic Agents; Indole-3-carbinol
• Other Study ID Numbers: CDR0000406002; KUMC-HSC-9139-2