Status:
UNKNOWN
Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 locor...
Detailed Description
OBJECTIVES: Primary * Determine complete response in patients with locoregionally extensive or metastatic differentiated thyroid cancer treated with rosiglitazone. Secondary * Compare the long-ter...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00098852
Start Date
October 1 2004
Last Update
January 6 2014
Active Locations (1)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115