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Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: December 8, 2004
Last updated: January 3, 2014
Last verified: January 2009

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 Intervention Phase
Head and Neck Cancer Drug: rosiglitazone maleate Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Radioiodine uptake and thyroglobulin level at 6 months and 1 year

Secondary Outcome Measures:
  • Side effects of drug at 2 months

Estimated Enrollment: 25
Study Start Date: October 2004
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Hemoglobin ≥ 10 g/dL
  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 50,000/mm^3


  • ALT ≤ 2 times upper limit of normal


  • Creatinine ≤ 1.5 mg/dL


  • No New York Heart Association class III or IV cardiac disease


  • 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


Biologic therapy

  • Not specified


  • More than 3 months since prior chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent levothyroxine


  • See Disease Characteristics
  • No prior cumulative dose of radioiodine ≥ 800 mCi
  • Prior adjuvant or therapeutic external beam radiotherapy allowed


  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00098852

United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Principal Investigator: Electron Kebebew, MD University of California, San Francisco
  More Information

Kebebew E, Reiff E, Greenspan FS, et al.: Rosiglitazone treatment induces radioiodine uptake in some patients with radioiodine-negative thyroglobulin-positive differentiated thyroid cancer. [Abstract] The Endocrine Society's 87th Annual Meeting, 4-7 June 2005, San Diego, CA. A-P3-573, 2005. Also available online. Last accessed February 21, 2006.

Responsible Party: Electron Kebebew, UCSF Helen Diller Family Comprehensive Cancer Center Identifier: NCT00098852     History of Changes
Other Study ID Numbers: CDR0000398114
Study First Received: December 8, 2004
Last Updated: January 3, 2014

Keywords provided by National Cancer Institute (NCI):
recurrent thyroid cancer
stage II follicular thyroid cancer
stage IV follicular thyroid cancer
stage II papillary thyroid cancer
stage IV papillary thyroid cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Thyroid Diseases
Thyroid Neoplasms
Neoplasms by Site
Endocrine System Diseases
Endocrine Gland Neoplasms
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on August 22, 2017