Status:
TERMINATED
Iodine I 131 in Treating Patients With Thyroid Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-100 years
Phase:
NA
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 pat...
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 clinica...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00416949
Start Date
April 1 2006
End Date
October 1 2009
Last Update
July 18 2018
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410