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:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00098852
First received: December 8, 2004
Last updated: January 3, 2014
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: rosiglitazone maleate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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

Secondary Outcome Measures:
  • Side effects of drug at 2 months [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: October 2004
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098852

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Electron Kebebew, MD University of California, San Francisco
  More Information

Additional Information:
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.

Responsible Party: Electron Kebebew, UCSF Helen Diller Family Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00098852     History of Changes
Other Study ID Numbers: CDR0000398114, UCSF-03201, UCSF-H28355-22994-01, GSK-UCSF-H28355-22994-01
Study First Received: December 8, 2004
Last Updated: January 3, 2014
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent thyroid cancer
stage II follicular thyroid cancer
stage IV follicular thyroid cancer
stage II papillary thyroid cancer
stage IV papillary thyroid cancer

Additional relevant MeSH terms:
Thyroid Neoplasms
Head and Neck Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Endocrine System Diseases
Thyroid Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014