Unspecified Adult Solid Tumor, Protocol SpecificPhase 1IRB 2004-535NCT00098969
UMCC 2003-064 Resveratrol in Preventing Cancer in Healthy Participants
A Phase 1 study testing resveratrol in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 2 sites in 2 countries.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of resveratrol may prevent cancer. PURPOSE: This phase I trial is studying the side effects and best dose of resveratrol in preventing cancer in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- resveratrol
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Healthy participants
PATIENT CHARACTERISTICS:
Age
- 18 to 80
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Platelet count 120,000-450,000mm^3
- Hemoglobin 10.5-17.5 g/dL for women OR 11.5-19.0 g/dL for men
Hepatic
- Bilirubin 0.05-1.2 mg/dL
- AST and ALT < 1.5 times normal
Renal
- Creatinine normal
- Urinalysis normal
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile participants must use effective contraception
- Willing to abstain from ingesting large quantities of resveratrol-containing foods
- Willing to spend 24 hours in the hospital
- No cancer diagnosis that is currently under treatment, is clinically detectable, or that has been treated within the past 5 years except basal cell or squamous cell skin cancer
- No concurrent excessive alcohol intake (>21 units per week for men; 14 units per week for women)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Concurrent hormone replace ment therapy allowed
- Concurrent oral or depot contraceptives allowed
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 2 weeks since prior and no concurrent vitamin supplements of any type
- More than 6 months since prior and no concurrent participation in any other experimental study
- No other concurrent chronic medications, including over-the-counter medications, herbal/natural preparations, or dietary supplements
- No other concurrent prescribed medication
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
United Kingdom1 site
Leicester Royal Infirmary
Leicester, England, LE2 7LX
About this study
Official title: Phase I Single-Dose Safety and Phamacokinetics Clinical Study of Resveratrol AKA IRB 2003-424
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of resveratrol may prevent cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of resveratrol in preventing cancer in healthy participants.
Read the detailed description
OBJECTIVES:
- Determine the concentration of resveratrol and its metabolites in the plasma, urine, and feces of healthy participants.
- Correlate dose with systemic concentration of this drug and its metabolites in these participants.
- Determine the safety of this drug in these participants.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Beginning 5 days before study drug administration, participants are put on a controlled diet (avoiding all resveratrol-containing food or drink) for washout. Participants receive oral resveratrol once on day 1.
Cohorts of 10 participants receive escalating doses of resveratrol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 10 participants experience dose-limiting toxicity. A total of 16 participants are treated at the MTD.
Participants are followed at 2 and 7 days.
PROJECTED ACCRUAL: A total of 10-40 participants will be accrued for this study within 6 months.
- Being tested
- resveratrol
- 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.
resveratrolDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2004 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Dean E. Brenner, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00098969
- Sponsor's protocol ID
- CDR0000396464
- Other IDs
- P30CA046592, CCUM-2004-0535, CCUM-2062
- Acronym
- IRB 2004-535
- Status last verified
- Mar 2010
- First submitted
- 8 Dec 2004
- Last updated
- 17 Dec 2012
- Results posted
- No
Publications
Boocock DJ, Gescher AJ, Brown V, et al.: Phase I single-dose safety and pharmacokinetics clinical study of the potential cancer chemopreventive agent resveratrol. [Abstract] American Association for Cancer Research: 97th Annual Meeting, April 1-5, 2006, Washington, DC. 2006.
Brown VA, Patel KR, Viskaduraki M, Crowell JA, Perloff M, Booth TD, Vasilinin G, Sen A, Schinas AM, Piccirilli G, Brown K, Steward WP, Gescher AJ, Brenner DE. Repeat dose study of the cancer chemopreventive agent resveratrol in healthy volunteers: safety, pharmacokinetics, and effect on the insulin-like growth factor axis. Cancer Res. 2010 Nov 15;70(22):9003-11. doi: 10.1158/0008-5472.CAN-10-2364. Epub 2010 Oct 8.
PubMed 20935227
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Single-Dose Safety and Phamacokinetics Clinical Study of Resveratrol AKA IRB 2003-424
- ClinicalTrials.gov ID
- NCT00098969
- Acronym / sponsor ID
- IRB 2004-535 / CDR0000396464
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 2004
- First posted
- 9 Dec 2004 (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 resveratrol may prevent cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of resveratrol in preventing cancer in healthy participants.
Detailed description
OBJECTIVES:
- Determine the concentration of resveratrol and its metabolites in the plasma, urine, and feces of healthy participants.
- Correlate dose with systemic concentration of this drug and its metabolites in these participants.
- Determine the safety of this drug in these participants.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Beginning 5 days before study drug administration, participants are put on a controlled diet (avoiding all resveratrol-containing food or drink) for washout. Participants receive oral resveratrol once on day 1.
Cohorts of 10 participants receive escalating doses of resveratrol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 10 participants experience dose-limiting toxicity. A total of 16 participants are treated at the MTD.
Participants are followed at 2 and 7 days.
PROJECTED ACCRUAL: A total of 10-40 participants will be accrued for this study within 6 months.
Study design
- Primary purpose
- Prevention
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 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 |
|---|---|---|
| resveratrol | 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 17 Dec 2012.
- Results publicationBoocock DJ, Gescher AJ, Brown V, et al.: Phase I single-dose safety and pharmacokinetics clinical study of the potential cancer chemopreventive agent resveratrol. [Abstract] American Association for Cancer Research: 97th Annual Meeting, April 1-5, 2006, Washington, DC. 2006.
- Derived from this study: PubMed 20935227Brown VA, Patel KR, Viskaduraki M, Crowell JA, Perloff M, Booth TD, Vasilinin G, Sen A, Schinas AM, Piccirilli G, Brown K, Steward WP, Gescher AJ, Brenner DE. Repeat dose study of the cancer chemopreventive agent resveratrol in healthy volunteers: safety, pharmacokinetics, and effect on the insulin-like growth factor axis. Cancer Res. 2010 Nov 15;70(22):9003-11. doi: 10.1158/0008-5472.CAN-10-2364. Epub 2010 Oct 8.
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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.
Dean E. Brenner, MD principal investigator
University of Michigan Rogel Cancer Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing resveratrol in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 2 sites in 2 countries.
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 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. 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?
On the ClinicalTrials.gov record for NCT00098969, which also lists 2 linked publications.
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 17 Dec 2012.