Back to resultsA Pilot Clinical Trial for Poorly Differentiated Thyroid Cancer - Correlation to Retinoid and Peroxisome-proliferator-activated Receptor (PPARy) Expression
Primary Purpose
Thyroid Cancer
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bexarotene
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Cancer focused on measuring Not respond, Radioactive iodine, Therapy, Shows signs, Aggressive behavior
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- University of Colorado Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bexarotene
Arm Description
Open label - all patients receive intervention
Outcomes
Primary Outcome Measures
Change in Tumor Size
To assess the tumor response of recurrent or metastatic radioiodine resistant thyroid cancer to bexarotene therapy using standard RECIST criteria
Secondary Outcome Measures
Full Information
NCT ID
NCT00718770
First Posted
July 17, 2008
Last Updated
December 16, 2013
Sponsor
University of Colorado, Denver
Collaborators
American Cancer Society, Inc., Eisai Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00718770
Brief Title
A Pilot Clinical Trial for Poorly Differentiated Thyroid Cancer - Correlation to Retinoid and Peroxisome-proliferator-activated Receptor (PPARy) Expression
Official Title
Rexinoid Therapy for Poorly Differentiated Thyroid Cancer: A Pilot Clinical Trial and Correlation to Retinoid and PPARy Receptor Expression
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
American Cancer Society, Inc., Eisai Inc.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
Not respond, Radioactive iodine, Therapy, Shows signs, Aggressive behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bexarotene
Arm Type
Experimental
Arm Description
Open label - all patients receive intervention
Intervention Type
Drug
Intervention Name(s)
Bexarotene
Other Intervention Name(s)
LGD-1069
Intervention Description
Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2.
Primary Outcome Measure Information:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Klopper, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Clinical Trial for Poorly Differentiated Thyroid Cancer - Correlation to Retinoid and Peroxisome-proliferator-activated Receptor (PPARy) Expression
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