Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs such as rosiglitazone may make tumor cells more sensitive to radioactive iodine. PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with locoregionally extensive or metastatic thyroid cancer.

Detailed Description
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OBJECTIVES: Primary Determine complete response in patients with locoregionally extensive or metastatic differentiated thyroid cancer treated with rosiglitazone. Secondary Compare the long-term response of patients treated with this drug with historical controls. Determine the toxicity profile of this drug in these patients. Determine the presence/persistence of tumor in patients treated with this drug. Determine the quality of life of patients treated with this drug. Determine overall survival of patients treated with this drug. OUTLINE: This is a pilot study. Patients receive oral rosiglitazone once daily on weeks 1-8. Patients also receive oral liothyronine sodium twice daily on weeks 1-6 in preparation for radioactive iodine scan. Treatment continues in the absence of disease progression or unacceptable toxicity. At week 8, all patients undergo whole body radioactive iodine scan followed by a treatment dose of radioiodine to assess radioiodine uptake by tumor. Quality of life is assessed at baseline and at the end of study treatment. Patients are followed at 2 weeks, 1, 4, and 10 months, and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study.

Official Title
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A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: rosiglitazone maleate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of differentiated thyroid cancer Locoregionally extensive and/or metastatic disease Inoperable disease Failed prior conventional therapy that included total/near-total thyroidectomy AND radioactive iodine I 131 ablation therapy Elevated thyroglobulin (Tg) levels (> 3 ng/mL on thyroid hormone OR > 10 ng/mL off thyroid hormone) Tg-antibody positive patients are eligible despite the Tg level Radioactive iodine (RAI) scan showing no or therapeutically insignificant (< 1%) RAI uptake after thyroid hormone withdrawal Scan performed within the past 18 months PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic Hemoglobin ≥ 10 g/dL WBC ≥ 3,000/mm^3 Platelet count ≥ 50,000/mm^3 Hepatic ALT ≤ 2 times upper limit of normal Renal Creatinine ≤ 1.5 mg/dL Cardiovascular No New York Heart Association class III or IV cardiac disease Other Not pregnant No nursing within the past 3 months Negative pregnancy test Fertile patients must use effective contraception No allergy to thiazolidinediones No other malignancy except basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy More than 3 months since prior chemotherapy Endocrine therapy See Disease Characteristics No concurrent levothyroxine Radiotherapy See Disease Characteristics No prior cumulative dose of radioiodine ≥ 800 mCi Prior adjuvant or therapeutic external beam radiotherapy allowed Surgery See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rosiglitazone maleate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radioiodine uptake and thyroglobulin level at 6 months and 1 year |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of drug at 2 months |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent thyroid cancer, stage II follicular thyroid cancer, stage IV follicular thyroid cancer, stage II papillary thyroid cancer, stage IV papillary thyroid cancer