Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer

Phase 2

• Conditions: Head and Neck Cancer

• Registration Number: NCT00098852
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

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 Timeline

• Study Start: 2004-10
• Study First Submitted: 2004-12-08
• Study First Submitted QC: 2004-12-08
• Study First Posted: 2004-12-09
• Status Verified: 2009-01
• Primary Completion: 2010-06
• Last Update Submitted: 2014-01-03
• Last Update Posted: 2014-01-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radioiodine uptake and thyroglobulin level at 6 months and 1 year

Secondary Outcome Measures

Name	Time	Method
Side effects of drug at 2 months

Trial Locations

Locations (1)

UCSF Helen Diller Family Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States