Expired Study
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Kansas City, Kansas 66160


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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000406002


NCT ID:

NCT00100958


Secondary ID:

KUMC-HSC-9139-2


Study Acronym:


Brief Title:

Indole-3-Carbinol in Preventing Cancer in Healthy Participants


Official Title:

Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-Indolymethane (DIM) Nutritional Product


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Masking: Double-Blind, P


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Gregory Reed, PhD
Principal Investigator
University of Kansas

Study Dates

Start Date:November 2004
Verification Date:May 2006
Last Changed Date:July 23, 2008
First Received Date:January 7, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:indole-3-carbinol

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Kansas
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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