Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00100958
Indole-3-Carbinol in Preventing Cancer in Healthy Participants
A Phase 1 study testing indole-3-carbinol in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Kansas at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- indole-3-carbinol
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
About this study
Official title: Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-Indolymethane (DIM) Nutritional Product
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.
Read the 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.
- Being tested
- indole-3-carbinol
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indole-3-carbinolDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2005 (estimated)
- Study startNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Gregory Reed, PhD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100958
- Sponsor's protocol ID
- CDR0000406002
- Other IDs
- KUMC-HSC-9139-2
- Status last verified
- May 2006
- First submitted
- 7 Jan 2005
- Last updated
- 24 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-Indolymethane (DIM) Nutritional Product
- ClinicalTrials.gov ID
- NCT00100958
- Acronym / sponsor ID
- CDR0000406002
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2004
- First posted
- 10 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indole-3-carbinol | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Reed, PhD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing indole-3-carbinol in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Kansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2008.