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Iodine I 131 in Treating Patients With Thyroid Cancer

Primary Purpose

Head and Neck Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient-specific dosimetry
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient-specific 3D-RD Dosimetry

Arm Description

Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.

Outcomes

Primary Outcome Measures

Tumor Absorbed Dose
Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.

Secondary Outcome Measures

Full Information

First Posted
December 27, 2006
Last Updated
June 22, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00416949
Brief Title
Iodine I 131 in Treating Patients With Thyroid Cancer
Official Title
Dose-Response in Radionuclide Therapy of Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to loss of funding.
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient-specific 3D-RD Dosimetry
Arm Type
Experimental
Arm Description
Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
Intervention Type
Device
Intervention Name(s)
Patient-specific dosimetry
Intervention Description
Patient-specific 3D-RD dosimetry was applied to the data collected
Primary Outcome Measure Information:
Title
Tumor Absorbed Dose
Description
Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.
Time Frame
up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Sgouros, PhD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Iodine I 131 in Treating Patients With Thyroid Cancer

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