Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer
This trial is active, not recruiting.
|Condition||head and neck cancer|
|Sponsor||University of California, San Francisco|
|Collaborator||National Cancer Institute (NCI)|
|Start date||October 2004|
|End date||June 2010|
|Trial size||25 participants|
|Trial identifier||NCT00098852, CDR0000398114, GSK-UCSF-H28355-22994-01, UCSF-03201, UCSF-H28355-22994-01|
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.
Radioiodine uptake and thyroglobulin level at 6 months and 1 year
Side effects of drug at 2 months
Male or female participants at least 18 years old.
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
|Official title||A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer|
|Principal investigator||Electron Kebebew, MD|
|Description||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.|
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