Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information
Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | 18 and over | NCI, Pharmaceutical / Industry | UCSF-03201 UCSF-H28355-22994-01, GSK-UCSF-H28355-22994-01, NCT00098852 |
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.
Entry 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
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
Patient Characteristics:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Hemoglobin ≥ 10 g/dL
- WBC ≥ 3,000/mm3
- Platelet count ≥ 50,000/mm3
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
Expected Enrollment
25A total of 20-25 patients will be accrued for this study.
Outcomes
Primary Outcome(s)Radioiodine uptake and thyroglobulin level at 6 months and 1 year
Side effects of drug at 2 months
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.
Published ResultsKebebew 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.
Trial Lead Organizations
UCSF Helen Diller Family Comprehensive Cancer Center
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| Electron Kebebew, MD, Principal investigator(Contact information may not be current) | |
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| Registry Information | ||
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| Official Title | A Pilot Study of Rosiglitazone in Patients with Incurable Differentiated Thyroid Cancer | |
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| Trial Start Date | 2004-10-14 | |
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| Trial Completion Date | 2010-06-01 (estimated) | |
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| Registered in ClinicalTrials.gov | NCT00098852 | |
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| Date Submitted to PDQ | 2004-10-14 | |
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| Information Last Verified | 2009-01-13 | |
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| NCI Grant/Contract Number | CA82103 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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