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


Phase 1
18 Years
70 Years
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Principal Investigator

Gregory Reed, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Federal Government

Study ID:

CDR0000406002

NCT ID:

NCT00100958

Start Date:

November 2004

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353