Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer

University of California, San Francisco25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Head and Neck Cancer

Interventions

rosiglitazone maleateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Outcomes

Primary Outcomes

Radioiodine uptake and thyroglobulin level at 6 months and 1 year

Secondary Outcomes

Side effects of drug at 2 months

Data from ClinicalTrials.gov

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