Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer
Recruitment status was Active, not recruiting
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 Design:||Primary Purpose: Treatment|
|Official Title:||A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer|
- Radioiodine uptake and thyroglobulin level at 6 months and 1 year [ Designated as safety issue: No ]
- Side effects of drug at 2 months [ Designated as safety issue: Yes ]
|Study Start Date:||October 2004|
|Estimated Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
- 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.
|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|