Expired Study
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San Francisco, California 94115


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00098852


Primary Contact:

Principal Investigator
Electron Kebebew, MD
University of California, San Francisco


Backup Contact:

N/A


Location Contact:

San Francisco, California 94115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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