Iodine I 131 in Treating Patients With Thyroid Cancer

Head and Neck Cancer Clinical Trial

Official title:

Dose-Response in Radionuclide Therapy of Thyroid Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00416949
• Other study ID #: J0628
• Secondary ID: CDR0000522716R01
• Status: Terminated
• Phase: N/A
• Start date: April 2006
• Est. completion date: October 2009

Study information

• Verified date: June 2018
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Absorbed Dose	Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.	up to 4 years