Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT00098852|
Recruitment Status : Unknown
Verified January 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : December 9, 2004
Last Update Posted : January 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: rosiglitazone maleate||Phase 2|
- Determine complete response in patients with locoregionally extensive or metastatic differentiated thyroid cancer treated with rosiglitazone.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Official Title:||A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer|
|Study Start Date :||October 2004|
|Estimated Primary Completion Date :||June 2010|
- Radioiodine uptake and thyroglobulin level at 6 months and 1 year
- Side effects of drug at 2 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098852
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Electron Kebebew, MD||University of California, San Francisco|