Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer

A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer

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 Overview

• Status: Unknown
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: rosiglitazone maleate

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • UCSF Helen Diller Family Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Radioiodine uptake and thyroglobulin level at 6 months and 1 year

Secondary Outcome Measures

Outcome Measure
Side effects of drug at 2 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Electron Kebebew, MD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Anticipated): June 1, 2010

Study Registration Dates

• First Submitted: December 8, 2004
• First Submitted That Met QC Criteria: December 8, 2004
• First Posted (Estimate): December 9, 2004

Study Record Updates

• Last Update Posted (Estimate): January 6, 2014
• Last Update Submitted That Met QC Criteria: January 3, 2014
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: stage IV papillary thyroid cancer; stage IV follicular thyroid cancer; recurrent thyroid cancer; stage II follicular thyroid cancer; stage II papillary thyroid cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms; Hypoglycemic Agents; Physiological Effects of Drugs; Rosiglitazone
• Other Study ID Numbers: CDR0000398114; UCSF-03201; UCSF-H28355-22994-01; GSK-UCSF-H28355-22994-01