This trial is active, not recruiting.

Condition head and neck cancer
Treatment rosiglitazone maleate
Phase phase 2
Sponsor University of California, San Francisco
Collaborator National Cancer Institute (NCI)
Start date October 2004
End date June 2010
Trial size 25 participants
Trial identifier NCT00098852, CDR0000398114, GSK-UCSF-H28355-22994-01, UCSF-03201, UCSF-H28355-22994-01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

Radioiodine uptake and thyroglobulin level at 6 months and 1 year
time frame:

Secondary Outcomes

Side effects of drug at 2 months
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer
Principal investigator Electron Kebebew, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).