Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2009 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00098852

First received: December 8, 2004

Last updated: September 25, 2010

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

December 8, 2004

Last Updated Date

September 25, 2010

Start Date ^ICMJE

October 2004

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Radioiodine uptake and thyroglobulin level at 6 months and 1 year [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00098852 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Side effects of drug at 2 months [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Head and Neck Cancer

Intervention ^ICMJE

Drug: rosiglitazone maleate

Study Arm (s)

Not Provided

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00098852

Other Study ID Numbers ^ICMJE

CDR0000398114, UCSF-03201, UCSF-H28355-22994-01, GSK-UCSF-H28355-22994-01

Has Data Monitoring Committee

Not Provided

Responsible Party

Electron Kebebew, UCSF Helen Diller Family Comprehensive Cancer Center

Study Sponsor ^ICMJE

University of California, San Francisco

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Electron Kebebew, MD

University of California, San Francisco

Information Provided By

National Cancer Institute (NCI)

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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