Pioglitazone in Thyroid Cancers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01655719|
Recruitment Status : Completed
First Posted : August 2, 2012
Results First Posted : October 26, 2017
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancers That Contain the PAX8-PPARgamma Fusion Gene||Drug: Pioglitazone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Pioglitazone in Thyroid Cancers That Contain the PAX8-PPARgamma Fusion Gene|
|Actual Study Start Date :||April 2012|
|Actual Primary Completion Date :||March 31, 2017|
|Actual Study Completion Date :||March 31, 2017|
Experimental: Pioglitazone Treatment
If eligible, subjects can participate in 1 or both parts of this study as follows:
Part 1: In the initial main portion of the study subjects will receive 24 -28 weeks of therapy with pioglitazone at the dosage approved for the control of diabetes. Response will be evaluated per RECIST. Safety measure are outlined in the protocol including weekly weigh ins, calls, labs, exams, etc.
Part 2: A secondary protocol is then available to subjects who complete the main initial study with less than complete response per RECIST. They can undergo a radioiodine scan to see if the treatment with pioglitazone has sensitized their disease to radioiodine. If it has - they can pursue the radioiodine treatment.
Other Name: Actos
- Tumor Response (Change) [ Time Frame: Baseline and 24 weeks ]Response is measured by change in Tumor size (cm)
- Change in Serum Thyroglobulin [ Time Frame: Baseline and 24 weeks ]Determine if pioglitazone decreases serum thyroglobulin in patients with follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene.
- Toxicity [ Time Frame: 24 weeks ]Toxicities experienced by patients with PAX8-PPARgamma fusion gene-positive follicular-patterned thyroid carcinomas treated with pioglitazone are indicated by presence of Serious Adverse Events (that show relatedness).
- Biomarkers [ Time Frame: 24 weeks ]Define predictive markers of response or insensitivity to pioglitazone. Unstained tumor tissue slides from archival paraffin blocks, fresh biopsy specimens from measurable metastases, and blood samples (serum and peripheral blood cells) will be collected on enrolled patients who consented for the optional correlative studies. These will be used to identify factors that predict efficacy of pioglitazone. Analyses may include measures of expression of specific RNAs and proteins, and DNA sequence analysis.
- Sensitization to Radioiodine Therapy [ Time Frame: 24 weeks ]Determine if pioglitazone induces a clinically significant level of radioiodine uptake in the residual thyroid carcinoma, and if so, whether there is a therapeutic response to radioiodine. This will be addressed in a separate follow-up protocol available to subjects completing this study.
- Lipid Accumulation in Tumor [ Time Frame: 24 weeks ]Determine (by MRI) if pioglitazone induces lipid accumulation in follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655719
|United States, Colorado|
|University of Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ronald J Koenig, MD, PhD||University of Michigan|