Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00098852
• Other study ID #: CDR0000398114
• Secondary ID: UCSF-03201UCSF-H
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 8, 2004
• Last updated: January 3, 2014
• Start date: October 2004

Study information

• Verified date: January 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Thyroid Neoplasms

Intervention

Drug:
• rosiglitazone maleate

Locations

Country	Name	City	State
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radioiodine uptake and thyroglobulin level at 6 months and 1 year			No
Secondary	Side effects of drug at 2 months			Yes