A Pilot Clinical Trial for Poorly Differentiated Thyroid Cancer - Correlation to Retinoid and Peroxisome-proliferator-activated Receptor (PPARy) Expression
Study Details
Study Description
Brief 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.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bexarotene Open label - all patients receive intervention |
Drug: Bexarotene
Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Tumor Size [1 year]
To assess the tumor response of recurrent or metastatic radioiodine resistant thyroid cancer to bexarotene therapy using standard RECIST criteria
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject must have a histologically/cytologically confirmed diagnosis of papillary, follicular, or anaplastic thyroid cancer (any follicular cell derived thyroid cancer).
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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.
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Subjects must not be eligible for surgical resection.
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Subjects must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
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Subjects must have laboratory values that fall within certain ranges.
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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.
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Females of childbearing potential must have a negative pregnancy test prior to enrollment.
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All eligible subjects must be willing to use adequate contraception throughout the duration of the study.
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Subjects must be willing to submit a primary tumor tissue sample for immunohistochemical analysis.
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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)
Exclusion Criteria:
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Subjects with a known history of hyperlipidemia refractory to treatment.
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Subjects with a known history of hypertriglyceridemia refractory to treatment.
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Subjects with leukopenia below the reference range for the University of Colorado Hospital (UCH) laboratory.
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Subjects, who are pregnant, have a desire to become pregnant or are breastfeeding.
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Subjects who are unwilling or unable to comply with study medication administration, or study guidelines, as determined by the investigator.
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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.
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Subjects without radiographically assessable disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado Cancer Center | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
- American Cancer Society, Inc.
- Eisai Inc.
Investigators
- Principal Investigator: Joshua Klopper, MD, University of Colorado, Denver
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 07-0727.cc
Study Results
Participant Flow
| Recruitment Details | Patients were recruited from a medical clinic from 01/15/2009 to 01/14/2010 |
|---|---|
| Pre-assignment Detail | The patients must fit all inclusion criteria and have had a 4 week washout from any systemic or radiation therapy. As an open-label, single arm trial, there was no group assignment. Patients were excluded only if they did not meet inclusion or had exclusion criteria |
| Arm/Group Title | Bexarotene |
|---|---|
| Arm/Group Description | Open label - all patients received the intervention Bexarotene : Bexarotene was given by mouth once a day every day for 1 year. The dose used was 300 mg/m2. |
| Period Title: Overall Study | |
| STARTED | 10 |
| COMPLETED | 2 |
| NOT COMPLETED | 8 |
Baseline Characteristics
| Arm/Group Title | Bexarotene |
|---|---|
| Arm/Group Description | Open label - all patients receive intervention Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2. |
| Overall Participants | 10 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
5
50%
|
| >=65 years |
5
50%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
61.3
(8.5)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
8
80%
|
| Male |
2
20%
|
| Region of Enrollment (participants) [Number] | |
| United States |
10
100%
|
Outcome Measures
| Title | Change in Tumor Size |
|---|---|
| Description | To assess the tumor response of recurrent or metastatic radioiodine resistant thyroid cancer to bexarotene therapy using standard RECIST criteria |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Adults with radioiodine resistant metastatic follicular cell derived thyroid cancer |
| Arm/Group Title | Bexarotene |
|---|---|
| Arm/Group Description | Open label - all patients receive intervention Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2. |
| Measure Participants | 10 |
| Mean (Standard Deviation) [cm] |
4.7
(0.2)
|
Adverse Events
| Time Frame | 1 year | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Bexarotene | |
| Arm/Group Description | Open label - all patients receive intervention Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2. | |
All Cause Mortality |
||
| Bexarotene | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Bexarotene | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Bexarotene | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/10 (40%) | |
| Blood and lymphatic system disorders | ||
| hyperlipidemia | 4/10 (40%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Joshua Klopper, MD |
|---|---|
| Organization | University of Colorado School of Medicine |
| Phone | 303-724-3921 |
| joshua.klopper@ucdenver.edu |
- 07-0727.cc