Neoplasms

Gland and Hormone Related Diseases

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Thyroid Neoplasms

Thyroid Diseases

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Endocrine Gland Neoplasms

Head and Neck Neoplasms

Hypoglycemic Agents

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Pioglitazone

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.

Ronald J Koenig, MD, PhD

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.

Pioglitazone in Thyroid Cancers

Phase 2 Study of Pioglitazone in Thyroid Cancers That Contain the PAX8-PPARgamma Fusion Gene

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.

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.

Determine (by MRI) if pioglitazone induces lipid accumulation in follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene.

Response is measured by change in Tumor size (cm)

Determine if pioglitazone decreases serum thyroglobulin in patients with follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene.

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).

National Cancer Institute (NCI)

University of Michigan

Professor

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.

Pioglitazone Treatment

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Tim Muth

Baseline

24 weeks

Tumor Response (Change)

Change in Serum Thyroglobulin

Toxicity

Biomarkers

Sensitization to Radioiodine Therapy

Lipid Accumulation in Tumor

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.

Pioglitazone

Spots Global Cancer Trial Database for Pioglitazone in Thyroid Cancers

Trial Identification

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Study Description

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