Head and Neck Cancer
Conditions
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
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.
Interventions
Patient-specific 3D-RD dosimetry was applied to the data collected
Sponsors
National Cancer Institute (NCI)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Absorbed Dose | up to 4 years | Tumor absorbed doses (Gy) calculated using patient-specific dosimetry. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient-specific 3D-RD Dosimetry Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patients refused to participate | 5 |
Baseline characteristics
| Characteristic | Patient-specific 3D-RD Dosimetry |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Region of Enrollment United States | 9 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Tumor Absorbed Dose
Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.
Time frame: up to 4 years
Population: Was only able to analyze tumor data from 3 patients based on number of tumors that could be reliably imaged for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient-specific 3D-RD Dosimetry | Tumor Absorbed Dose | 6.6 Gy | Standard Deviation 4.54 |