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A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Radioiodine uptake and thyroglobulin level at 6 months and 1 year

Safety Issue:

No

Principal Investigator

Electron Kebebew, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000398114

NCT ID:

NCT00098852

Start Date:

October 2004

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent thyroid cancer
  • stage II follicular thyroid cancer
  • stage IV follicular thyroid cancer
  • stage II papillary thyroid cancer
  • stage IV papillary thyroid cancer
  • Thyroid Neoplasms
  • Head and Neck Neoplasms

Name

Location

UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115