Iodine I 131 in Treating Patients With Thyroid Cancer

Johns Hopkins Medicine

Status

Terminated

Conditions

Head and Neck Cancer

Treatments

Device: Patient-specific dosimetry

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00416949

CDR0000522716 (Registry Identifier)

J0628

NA_00002264 (Other Identifier)

R01CA116477-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Radioactive iodine kills thyroid cancer cells by giving off radiation.

PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I 131 works in treating patients with thyroid cancer.

Full description

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.

Enrollment

9 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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