Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer
Intervention: rosiglitazone maleate (Drug)
Phase: Phase 2
Status: Active, not 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 phase II 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: Primary Purpose: 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
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.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 2004
Last updated: January 3, 2014
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