Iodine I 131 in Treating Patients With Thyroid Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00416949
First received: December 27, 2006
Last updated: August 6, 2014
Last verified: May 2013
  Purpose

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.


Condition Intervention
Head and Neck Cancer
Procedure: computed tomography
Procedure: radionuclide imaging
Procedure: single photon emission computed tomography
Radiation: iodine I 131

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Dose-Response in Radionuclide Therapy of Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Relationship between estimated absorbed dose and normal organ toxicity [ Time Frame: July '06 to Sept '10 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Difference in the dose-response relationship between dosimetric methodologies [ Time Frame: July '06 to Sept '10 ] [ Designated as safety issue: No ]
  • Influence of prior therapy on the dose-response relationship for hematologic toxicity [ Time Frame: July '06 to Sept '10 ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: April 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1 Procedure: computed tomography Procedure: radionuclide imaging Procedure: single photon emission computed tomography Radiation: iodine I 131

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416949

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: George Sgouros, PhD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00416949     History of Changes
Other Study ID Numbers: JHOC-J0628, CDR0000522716
Study First Received: December 27, 2006
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Thyroid Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on September 18, 2014