Iodine I 131 in Treating Patients With Thyroid Cancer

OBJECTIVES:

- Determine the relationship between estimated absorbed dose of iodine I 131 and tumor
response or normal organ toxicity for different dosimetric measures, using data derived
from clinical radionuclide therapy studies in patients with thyroid cancer.

OUTLINE: Patients receive oral dosimetric iodine I 131 (^131I) on day 2 and then undergo
nuclear medicine imaging at 0.5-4 hours, 24, 48, and 72 hours after dosimetric ^131I.
Single-photon emission computed tomography (SPECT)/CT scans are performed at 0.5-4 hours and
24 or 48 hours over the head and neck region, including the salivary glands. Subsequent
SPECT/CT scans are performed over the candidate tumor sites. Patients undergo ^131I therapy
on day 11.

Saliva is collected on days 1 and 2, weeks 2 and 4, and months 3 and 6 to measure saliva flow
rate. Blood is collected at baseline and periodically during study to measure FLT3 ligand
levels.

PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

- Diagnosis of thyroid cancer

- Measurable disease by CT scan or nuclear medicine imaging

- Eligible, by standard of care criteria, for iodine I 131 therapy

PATIENT CHARACTERISTICS:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective non-barrier method contraception (e.g., combined
or progesterone-only oral contraceptive pill, intrauterine device, depot progesterone,
or stable relationship with a partner who has had a vasectomy)

- No other malignancy within the past 5 years except squamous cell or basal cell
carcinoma of the skin

- No nonthyroidal conditions known to affect iodine I 131 uptake (e.g., New York Heart
Association class III or IV congestive heart failure or renal failure)

- No alcoholism or drug abuse within the past 2 years

- No severe emotional, behavioral, or psychiatric problems that would preclude study
compliance (e.g., severe claustrophobia)

PRIOR CONCURRENT THERAPY:

- No intravenous water-soluble radiographic contrast within the past 4 weeks

- No iodinated contrast agent within the past 3 months

- No concurrent drugs that may affect thyroid or renal function (e.g., renal drugs,
lithium, amiodarone, other iodine-containing medication, or corticosteroids)

- No other concurrent investigational drugs