Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	UCSF-03201 UCSF-H28355-22994-01, GSK-UCSF-H28355-22994-01, NCT00098852

Objectives

Primary

1. Determine complete response in patients with locoregionally extensive or metastatic differentiated thyroid cancer treated with rosiglitazone.

Secondary

1. Compare the long-term response of patients treated with this drug with historical controls.
2. Determine the toxicity profile of this drug in these patients.
3. Determine the presence/persistence of tumor in patients treated with this drug.
4. Determine the quality of life of patients treated with this drug.
5. Determine overall survival of patients treated with this drug.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Hemoglobin ≥ 10 g/dL
• WBC ≥ 3,000/mm³
• Platelet count ≥ 50,000/mm³

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

Expected Enrollment

A total of 20-25 patients will be accrued for this study.

Outcomes

Radioiodine uptake and thyroglobulin level at 6 months and 1 year

Side effects of drug at 2 months

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.

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.

Trial Contact Information

Trial Lead Organizations

UCSF Helen Diller Family Comprehensive Cancer Center

Electron Kebebew, MD, Principal investigator(Contact information may not be current)		Ph: 415-885-3617; 800-888-8664 Email: Electron.Kebebew@ucsfmedctr.org

Registry Information
Official Title		A Pilot Study of Rosiglitazone in Patients with Incurable Differentiated Thyroid Cancer
Trial Start Date		2004-10-14
Trial Completion Date		2010-06-01 (estimated)
Registered in ClinicalTrials.gov		NCT00098852
Date Submitted to PDQ		2004-10-14
Information Last Verified		2009-01-13
NCI Grant/Contract Number		CA82103

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