Overview

Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, San Francisco
Collaborator:
National Cancer Institute (NCI)
Treatments:
Rosiglitazone
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