Iodine I 131 in Treating Patients With Thyroid Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

Patient-specific dosimetryDEVICE

Patient-specific 3D-RD dosimetry was applied to the data collected

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Tumor Absorbed Dose

Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.

Time frame: up to 4 years

Data from ClinicalTrials.gov

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