Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer - Full Text View

Sponsor:	University of California, San Francisco
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00098852

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 II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Thyroid Cancer

Drug Information available for: Rosiglitazone Rosiglitazone Maleate Thyroid

U.S. FDA Resources

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

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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Electron Kebebew, MD

University of California, San Francisco

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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:	UCSF Helen Diller Family Comprehensive Cancer Center ( Electron Kebebew )
Study ID Numbers:	CDR0000398114, UCSF-03201, UCSF-H28355-22994-01, GSK-UCSF-H28355-22994-01
Study First Received:	December 8, 2004
Last Updated:	February 14, 2009
ClinicalTrials.gov Identifier:	NCT00098852 History of Changes
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:

Neoplasms
Hypoglycemic Agents
Neoplasms by Site
Thyroid Neoplasms
Head and Neck Neoplasms
Physiological Effects of Drugs

Endocrine System Diseases
Rosiglitazone
Pharmacologic Actions
Thyroid Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010