Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: rosiglitazone maleate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer |
- Radioiodine uptake and thyroglobulin level at 6 months and 1 year [ Designated as safety issue: No ]
- Side effects of drug at 2 months [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 25 |
| Study Start Date: | October 2004 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Principal Investigator: | Electron Kebebew, MD | University of California, San Francisco |
More Information
Additional Information:
Publications:
| Responsible Party: | Electron Kebebew, UCSF Helen Diller Family Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00098852 History of Changes |
| Other Study ID Numbers: | CDR0000398114, UCSF-03201, UCSF-H28355-22994-01, GSK-UCSF-H28355-22994-01 |
| Study First Received: | December 8, 2004 |
| Last Updated: | September 25, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent thyroid cancer stage II follicular thyroid cancer stage IV follicular thyroid cancer stage II papillary thyroid cancer stage IV papillary thyroid cancer |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Head and Neck Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Endocrine System Diseases Thyroid Diseases |
Maleic acid Rosiglitazone Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013