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Status:

COMPLETED

Indole-3-Carbinol in Preventing Cancer in Healthy Participants

Lead Sponsor:

University of Kansas

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18-70 years

Phase:

PHASE1

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...

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 p...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00100958

    Start Date

    November 1 2004

    Last Update

    July 24 2008

    Active Locations (1)

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    Page 1 of 1 (1 locations)

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

    Kansas City, Kansas, United States, 66160-7357