A Pilot Clinical Trial for Poorly Differentiated Thyroid Cancer - Correlation to Retinoid and Peroxisome-proliferator-activated Receptor (PPARy) Expression
|ClinicalTrials.gov Identifier: NCT00718770|
Recruitment Status : Completed
First Posted : July 21, 2008
Results First Posted : January 17, 2014
Last Update Posted : January 17, 2014
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|
|Thyroid Cancer||Drug: Bexarotene||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rexinoid Therapy for Poorly Differentiated Thyroid Cancer: A Pilot Clinical Trial and Correlation to Retinoid and PPARy Receptor Expression|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||February 2013|
Open label - all patients receive intervention
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 Name: LGD-1069
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718770
|United States, Colorado|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Joshua Klopper, MD||University of Colorado, Denver|