Clinical trial NCT00416949: Iodine I 131 in Treating Patients With Thyroid Cancer
Official title: Dose-Response in Radionuclide Therapy of Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: anaplastic thyroid cancer
insular thyroid cancer
thyroid gland medullary carcinoma
recurrent thyroid cancer
stage I follicular thyroid cancer
stage I papillary thyroid cancer
stage II follicular thyroid cancer
stage II papillary thyroid cancer
stage III follicular thyroid cancer
stage III papillary thyroid cancer
stage IVA follicular thyroid cancer
stage IVB follicular thyroid cancer
stage IVC follicular thyroid cancer
stage IVA papillary thyroid cancer
stage IVB papillary thyroid cancer
stage IVC papillary thyroid cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-12-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Tumor Absorbed Dose
timeFrame: up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: George Sgouros, PhD
role: STUDY_CHAIR
References: