Thyroid CancerEarly Phase 1NCT00718770
A Pilot Clinical Trial for Poorly Differentiated Thyroid Cancer - Correlation to Retinoid and Peroxisome-proliferator-activated Receptor (PPARy) Expression
A Early Phase 1 study testing Bexarotene in people with Thyroid Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about a drug called bexarotene for the treatment of advanced thyroid cancer. Subjects are asked to be in this study because they have thyroid cancer that will not respond to radioactive iodine therapy and shows signs of aggressive behavior. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Bexarotene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Feb 2013
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject must have a histologically/cytologically confirmed diagnosis of papillary, follicular, or anaplastic thyroid cancer (any follicular cell derived thyroid cancer).
- Subjects must have evidence of follicular cell-derived thyroid cancer progression. In patients with anatomically stable disease, PET positive lesions will also be eligible given the poor prognostic risk for PET positive thyroid cancer.
- Subjects must not be eligible for surgical resection.
- Subjects must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Subjects must have laboratory values that fall within certain ranges.
- Subjects must be age 18 years or older.
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- Subjects must provide written informed consent prior to any study procedures being performed.
- Females of childbearing potential must have a negative pregnancy test prior to enrollment.
- All eligible subjects must be willing to use adequate contraception throughout the duration of the study.
- Subjects must be willing to submit a primary tumor tissue sample for immunohistochemical analysis.
- Subjects have the option of providing one additional test tube of blood taken at baseline, 6 months and 1 year for banking of plasma for potential future studies (no genetic testing will be conducted). The current planned analysis is for the assessment of a potential peripheral marker for rexinoid responsive cancer - leukemia inhibitory factor (LIF)
Who cannot join
- Subjects with a known history of hyperlipidemia refractory to treatment.
- Subjects with a known history of hypertriglyceridemia refractory to treatment.
- Subjects with leukopenia below the reference range for the University of Colorado Hospital (UCH) laboratory.
- Subjects, who are pregnant, have a desire to become pregnant or are breastfeeding.
- Subjects who are unwilling or unable to comply with study medication administration, or study guidelines, as determined by the investigator.
- Subjects with any prior history of malignancy with the exception of adequately treated basal cell skin cancer, in situ cervical cancer or other cancer for which the subject has been disease free for 3 years or more.
- Subjects without radiographically assessable disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Cancer Center
Aurora, Colorado, 80045
About this study
Official title: Rexinoid Therapy for Poorly Differentiated Thyroid Cancer: A Pilot Clinical Trial and Correlation to Retinoid and PPARy Receptor Expression
This study plans to learn more about a drug called bexarotene for the treatment of advanced thyroid cancer. Subjects are asked to be in this study because they have thyroid cancer that will not respond to radioactive iodine therapy and shows signs of aggressive behavior.
Bexarotene has been FDA approved for the treatment of a type of skin cancer called cutaneous T-cell lymphoma, but has not been FDA approved for this use. Bexarotene is investigational in the treatment of thyroid cancer.
Read more
The purpose of this research study is to test how well the study drug works in humans. The study doctors want to know if:
- The subjects thyroid cancer gets smaller while you are taking the study drug.
- The subjects thyroid cancer takes up radioactive iodine better after treatment with the study drug than before treatment.
- Conditions
- Thyroid Cancer
- Being tested
- Bexarotene
- Keywords
- Not respond, Radioactive iodine, Therapy, Shows signs, Aggressive behavior
- Medical subject headings
- Thyroid Neoplasms, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BexaroteneDrug
Also called LGD-1069
Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2.
| Study group | Role | What they receive |
|---|---|---|
| Bexarotene | Experimental | Open label - all patients receive intervention Receives: Drug: Bexarotene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tumor Size
To assess the tumor response of recurrent or metastatic radioiodine resistant thyroid cancer to bexarotene therapy using standard RECIST criteria
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Joshua Klopper, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718770
- Sponsor's protocol ID
- 07-0727.cc
- Status last verified
- Dec 2013
- First submitted
- 17 Jul 2008
- Last updated
- 17 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rexinoid Therapy for Poorly Differentiated Thyroid Cancer: A Pilot Clinical Trial and Correlation to Retinoid and PPARy Receptor Expression
- ClinicalTrials.gov ID
- NCT00718770
- Acronym / sponsor ID
- 07-0727.cc
- Conditions
- Thyroid Cancer
- Keywords
- Not respond, Radioactive iodine, Therapy, Shows signs, Aggressive behavior
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Eisai Inc.
- Study start
- Nov 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Posted 17 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study plans to learn more about a drug called bexarotene for the treatment of advanced thyroid cancer. Subjects are asked to be in this study because they have thyroid cancer that will not respond to radioactive iodine therapy and shows signs of aggressive behavior.
Bexarotene has been FDA approved for the treatment of a type of skin cancer called cutaneous T-cell lymphoma, but has not been FDA approved for this use. Bexarotene is investigational in the treatment of thyroid cancer.
The purpose of this research study is to test how well the study drug works in humans. The study doctors want to know if:
- The subjects thyroid cancer gets smaller while you are taking the study drug.
- The subjects thyroid cancer takes up radioactive iodine better after treatment with the study drug than before treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bexarotene | Experimental | Drug: BexaroteneOpen label - all patients receive intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject must have a histologically/cytologically confirmed diagnosis of papillary, follicular, or anaplastic thyroid cancer (any follicular cell derived thyroid cancer).
- Subjects must have evidence of follicular cell-derived thyroid cancer progression. In patients with anatomically stable disease, PET positive lesions will also be eligible given the poor prognostic risk for PET positive thyroid cancer.
- Subjects must not be eligible for surgical resection.
- Subjects must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Subjects must have laboratory values that fall within certain ranges.
Key exclusion criteria (7 listed)
- Subjects with a known history of hyperlipidemia refractory to treatment.
- Subjects with a known history of hypertriglyceridemia refractory to treatment.
- Subjects with leukopenia below the reference range for the University of Colorado Hospital (UCH) laboratory.
- Subjects, who are pregnant, have a desire to become pregnant or are breastfeeding.
- Subjects who are unwilling or unable to comply with study medication administration, or study guidelines, as determined by the investigator.
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 |
|---|---|---|
| BexaroteneAlso: LGD-1069Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2. | Drug | Bexarotene |
Primary outcome
Change in Tumor Size
Time frame: 1 year
To assess the tumor response of recurrent or metastatic radioiodine resistant thyroid cancer to bexarotene therapy using standard RECIST criteria
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
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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.
Joshua Klopper, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bexarotene in people with Thyroid Cancer, run by University of Colorado, Denver 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 11 inclusion and 7 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 17 Jan 2014. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Tumor Size (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 17 Jan 2014; AzTrials last refreshed its copy on 1 Nov 2026.