Pioglitazone in Follicular or Follicular Variant of Papillary Thyroid Cancers
Through this trial the investigators hope to learn if a drug, Actos (pioglitazone), is useful in treating a certain kind of metastatic thyroid cancer. Actos is approved by the FDA to treat diabetes. It has not been approved by the FDA to treat cancer, so its use in this study is considered experimental.
Follicular Thyroid Carcinoma
Follicular Variant of Papillary Thyroid Carcinoma
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of Pioglitazone in Follicular-patterned Thyroid Cancers That Contain the PAX8-PPARgamma Fusion Gene|
- Tumor response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Determine the overall response (complete and partial response) rates of patients with PAX8-PPARgamma fusion gene-positive follicular-patterned thyroid carcinomas treated with pioglitazone.
- Decrease in serum thyroglobulin [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Measure toxicities experienced by patients with PAX8-PPARgamma fusion gene-positive follicular-patterned thyroid carcinomas treated with pioglitazone.
- Biomarkers [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Determine (by MRI) if pioglitazone induces lipid accumulation in follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene.
|Study Start Date:||April 2012|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655719
|Contact: Timothy Muth, MSemail@example.com|
|United States, Colorado|
|University of Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Lauren Suppes Lauren.Suppes@UCDenver.edu|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Timothy Muth, MS firstname.lastname@example.org|
|United States, Ohio|
|Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Jennifer Brown email@example.com|
|United States, Pennsylvania|
|University of Pennsylvania||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Thelma McCloskey Thelma.McCloskey@uphs.upenn.edu|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Madonna Pool MMPool@mdanderson.org|
|Principal Investigator:||Ronald J Koenig, MD, PhD||University of Michigan|