Indole-3-Carbinol in Preventing Cancer in Healthy Participants

NCT ID: NCT00100958

Last Updated: 2008-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

indole-3-carbinol

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Kansas

OTHER

Sponsor Role: lead

Principal Investigators

Gregory Reed, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

KUMC-HSC-9139-2

Identifier Type: -

Identifier Source: secondary_id

CDR0000406002

Identifier Type: -

Identifier Source: org_study_id