Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on May 09, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer
Intervention: rosiglitazone maleate (Drug); biological therapy (Procedure); differentiation therapy (Procedure); radiosensitization (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s):
Electron Kebebew, MD, Principal Investigator, Affiliation: University of California, San Francisco
Summary
RATIONALE: Drugs such as rosiglitazone may make tumor cells more sensitive to radioactive iodine.
PURPOSE: This clinical trial is studying how well rosiglitazone works in treating patients with locoregionally extensive or metastatic thyroid cancer.
Clinical Details
Official title:
A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer
Study design: Interventional, Treatment
Primary outcome: Radioiodine uptake and thyroglobulin level at 6 months and 1 year
Secondary outcome: Side effects of drug at 2 months
Detailed description:
OBJECTIVES:
Primary
* Determine complete response in patients with locoregionally extensive or metastatic poorly 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.
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of poorly 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 and Contacts
UCSF Comprehensive Cancer Center, San Francisco, California 94115, United States; Recruiting
Clinical Research Support Services, Phone: 877-827-3222
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Last updated: March 5, 2007
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