A Pilot Clinical Trial for Poorly Differentiated Thyroid Cancer - Correlation to Retinoid and Peroxisome-proliferator-activated Receptor (PPARy) 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.
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:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Rexinoid Therapy for Poorly Differentiated Thyroid Cancer: A Pilot Clinical Trial and Correlation to Retinoid and PPARy Receptor Expression|
- Change in Tumor Size [ Time Frame: 1 year ] [ Designated as safety issue: No ]To assess the tumor response of recurrent or metastatic radioiodine resistant thyroid cancer to bexarotene therapy using standard RECIST criteria
|Study Start Date:||November 2008|
|Study Completion Date:||February 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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
|United States, Colorado|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Joshua Klopper, MD||University of Colorado, Denver|