Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer

University of California San Francisco (UCSF)

Status and phase: Unknown; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: rosiglitazone maleate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00098852

UCSF-03201

UCSF-H28355-22994-01

GSK-UCSF-H28355-22994-01

CDR0000398114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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