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Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rosiglitazone maleate
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent thyroid cancer, stage II follicular thyroid cancer, stage IV follicular thyroid cancer, stage II papillary thyroid cancer, stage IV papillary thyroid cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Radioiodine uptake and thyroglobulin level at 6 months and 1 year

Secondary Outcome Measures

Side effects of drug at 2 months

Full Information

First Posted
December 8, 2004
Last Updated
January 3, 2014
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00098852
Brief Title
Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer
Official Title
A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
recurrent thyroid cancer, stage II follicular thyroid cancer, stage IV follicular thyroid cancer, stage II papillary thyroid cancer, stage IV papillary thyroid cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rosiglitazone maleate
Primary Outcome Measure Information:
Title
Radioiodine uptake and thyroglobulin level at 6 months and 1 year
Secondary Outcome Measure Information:
Title
Side effects of drug at 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Electron Kebebew, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
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Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer

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