Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer

January 3, 2014 updated by: University of California, San Francisco

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Cancer

Clinical Trials on rosiglitazone maleate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe