Indole-3-Carbinol in Preventing Cancer in Healthy Participants
This study has been completed.
Sponsor:
University of Kansas
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
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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 |
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
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 Protective Agents Physiological Effects of Drugs |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013