A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Radioiodine uptake and thyroglobulin level at 6 months and 1 year
Safety Issue:
No
Principal Investigator
Electron Kebebew, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Federal Government
Study ID:
CDR0000398114
NCT ID:
NCT00098852
Start Date:
October 2004
Completion Date:
Related Keywords:
- Head and Neck Cancer
- recurrent thyroid cancer
- stage II follicular thyroid cancer
- stage IV follicular thyroid cancer
- stage II papillary thyroid cancer
- stage IV papillary thyroid cancer
- Thyroid Neoplasms
- Head and Neck Neoplasms
Name | Location |
|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
