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Oral LeukoplakiaPhase 2NCT00369174

Rosiglitazone Maleate in Treating Patients With Oral Leukoplakia

A Phase 2 study testing rosiglitazone maleate and laboratory biomarker analysis in people with Oral Leukoplakia, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial is studying how well rosiglitazone works in preventing oral cancer in patients with oral leukoplakia. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of rosiglitazone may keep cancer from forming in patients with oral leukoplakia Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oral Leukoplakia
What is being tested?
rosiglitazone maleate and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Jun 2006to Aug 2007
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females with a suspected or histologically confirmed index oral premalignant lesion (excluding carcinoma in situ), 12mm or greater in size that has not been biopsied in the past 6 weeks; each index lesion must be either a:
  • dysplastic measurable leukoplakia or erythroplakia in the oral cavity or accessible oropharynx, or
  • hyperplastic leukoplakia of high-risk sites, lateral and ventral tongue and floor of mouth
  • The subject's life expectancy is > 12 weeks and Karnofsky performance score is 70-100%
  • Hemoglobin and hematocrit levels above the lower limit of normal
  • White blood cells >= 3,000/uL
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  • Platelets >= 125,000/uL
  • Total bilirubin =< 1.5 x ULN
  • AST (SGOT)/ALT (SGPT) =< 1.5 x ULN
  • BUN and serum creatinine =< 1.5 x ULN
  • LDH =< 1.5 x ULN
  • If the subject is female and of childbearing potential (women are considered not of childbearing potential if they are at least two years postmenopausal and/or surgically sterile), she:
  • has been using adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) since her last menses and will use adequate contraception during the study, AND
  • is not lactating, AND
  • has a documented negative serum pregnancy test within 14 days prior to randomization
  • The subject has discontinued any other oral cancer chemopreventive therapy at least 12 weeks prior to the Baseline visit and all toxicities have been fully resolved; daily aspirin is permitted
  • The subject is willing and able to fully participate for the duration of the study
  • If applicable, the subject has been counseled on smoking cessation
  • The effects of rosiglitazone (Avandia) on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, and because rosiglitazone has been associated with fetal death and growth retardation in rats and rabbits and placental pathology in rats, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately and will be removed from the trial
  • Ability to understand and the willingness to sign a written informed consent document
  • The subject is of New York Heart Association (NYHA) Class 1 to 4 cardiac status

Who cannot join

  • The subject has active cancer or carcinoma in situ of the head and neck
  • The subject has a contraindication to biopsy
  • The subject has any history of congestive heart failure, any history of myocardial infarction, angina, or coronary artery disease within the past 6 months, or active cardiac disease
  • The subject exhibits clinical evidence of active liver disease, history of chronic liver disease or edema
  • The subject currently receives insulin, sulfonylurea or metformin (doses of rosiglitazone greater than 4 mg daily in combination with these therapies are not currently indicated; because this protocol uses the maximum recommended dose of 8 mg daily, subjects on insulin, sulfonylurea or metformin will be ineligible for participation in this trial); the subject is currently receiving thiazolidinediones; the subject is a diabetic not on treatment or hyperglycemic (has a random blood glucose level > 200 mg/dl); the subject has diabetic macular edema
  • The subject is currently receiving medical therapy for dysregulated blood sugar
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  • The subject has experienced jaundice with Rezulin® (troglitazone)
  • The subject has known hypersensitivity to rosiglitazone, Avandia, or any of its components
  • The subject has a history of colorectal cancer, familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC)
  • The subject has a history of invasive cancer within the past 18 months (excluding non-invasive bladder cancer, non-melanoma skin cancer and in situ cervical cancer); subjects (excluding those with a history of colorectal cancer, FAP or HNPCC) who received curative treatment and have shown no evidence of recurrence for 18 months will be eligible
  • The subject has had chemotherapy, immunotherapy, hormonal therapy (other than HRT for menopause), or radiation therapy within 18 months of the Baseline visit
  • The subject will need concurrent chemotherapy, radiotherapy, hormonal (other than HRT for menopause), or immunotherapy during the time of study
  • The subject has received any investigational medication within 30 days of the Baseline visit or is scheduled to receive an investigational drug during the course of the study
  • The subject participated in the study previously and was withdrawn
  • The subject is pregnant or nursing
  • Subjects who have had the study drug prior to this study
  • The subject has uncontrolled intercurrent illness including: ongoing or active infection, HIV, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Phase IIA Trial of Rosiglitazone (Avandia) for Oral Leukoplakia

This phase II trial is studying how well rosiglitazone works in preventing oral cancer in patients with oral leukoplakia. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of rosiglitazone may keep cancer from forming in patients with oral leukoplakia

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the rate of clinical response of oral premalignant lesions (OPL) to 12 weeks of therapy with rosiglitazone (Avandia), 8 mg daily, defined as greater than or equal to 50% reduction in the measured product of perpendicular dimension of the target lesion, or improvement in the degree of dysplasia.

SECONDARY OBJECTIVES:

  1. To determine the rate and degree of change of putative biomarkers of rosiglitazone efficacy including:

COX-2, cyclin D1, Ki-67, p21/waf1, PPAR gamma, K1 cytokeratin, involucrin, transglutaminase expressions, and TUNEL.

II. To estimate the correlation between DNA ploidy measurements in OPL with clinical response and or response of biomarkers to rosiglitazone therapy, and to estimate the efficacy of rosiglitazone therapy to normalize aberrant DNA ploidy in OPL.

III. To thoroughly assess smoking patterns among trial participants and to examine the relationship of smoking to treatment response.

IV. To assess the safety of this agent in short-term use in this population.

OUTLINE: This is a multicenter, open-label, nonrandomized study.

Patients receive oral rosiglitazone once daily. Treatment continues for 12 weeks in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed at 1 week.

Being tested
rosiglitazone maleate, laboratory biomarker analysis
Medical subject headings
Leukoplakia, Oral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rosiglitazone maleateDrug

    Also called Avandia, BRL49653, ROS

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00369174
Study groupRoleWhat they receive
Treatment (rosiglitazone maleate)ExperimentalPatients receive oral rosiglitazone once daily. Treatment continues for 12 weeks in the absence of unacceptable toxicity.
Receives: Drug: rosiglitazone maleate; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects who show complete or partial response in either clinical or histological outcomes

    Estimated together with 95% confidence interval. The confidence interval will be constructed using exact binomial confidence intervals (rather than the normal approximation).

    Measured: 12 weeks

Secondary outcomes (4)

  1. Tissue expressions of COX-2, cyclin D1, Ki-67, p21/waf1, PPAR gamma, K1 cytokeratin, involucrin, and transglutaminase, and tissues levels of apoptosis (assessed using TUNEL)

    Summarized at each time point using summary statistics such as the mean, median, and range. The changes in levels of these biomarkers will also be explored with similar summary statistics and with graphical methods as well.

    Measured: 12 weeks

  2. Tissue DNA ploidy

    Measured: 12 weeks

  3. Smoking and alcohol use

    Assessed descriptively. Fisher's exact test may be used to assess whether there is a significant association between smoking status and efficacy of rosiglitazone.

    Measured: Up to 12 weeks

  4. Adverse events defined as any untoward medical occurrence in a study participant, graded using the NCI CTCAE version 3.0

    Descriptively summarized in tabular form.

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionAug 2007

Resources

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00369174
Sponsor's protocol ID
NCI-2012-02968
Other IDs
2005-0485, N01CN35159, P30CA008748, P30CA016672
Status last verified
Jan 2013
First submitted
24 Aug 2006
Last updated
13 Feb 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rosiglitazone maleate and laboratory biomarker analysis in people with Oral Leukoplakia, run by National Cancer Institute (NCI) 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?

The sponsor lists 21 inclusion and 17 exclusion criteria. 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 13 Feb 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

What does the primary outcome measure?

Proportion of subjects who show complete or partial response in either clinical or histological outcomes (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00369174.

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 13 Feb 2013.

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