Iodine I 131 in Treating Patients With Thyroid Cancer

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00416949
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 42
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Device: Patient-specific dosimetry	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Dose-Response in Radionuclide Therapy of Thyroid Cancer
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Patient-specific dosimetry; Patient-specific 3D-RD dosimetry was applied to the data collected

Outcome Measures

Primary Outcome Measures

1. Tumor Absorbed Dose [up to 4 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410

Sponsors and Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• National Cancer Institute (NCI)

Investigators

• Study Chair: George Sgouros, PhD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT00416949
• Other Study ID Numbers: J0628; CDR0000522716; R01CA116477-01A1; NA_00002264
• First Posted: Dec 28, 2006
• Last Update Posted: Jul 18, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: 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: Thyroid Neoplasms

Study Results

Participant Flow

Arm/Group Title	Patient-specific 3D-RD Dosimetry
Arm/Group Description	Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
Period Title: Overall Study
STARTED	9
COMPLETED	4
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Patient-specific 3D-RD Dosimetry
Arm/Group Description	Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
Overall Participants	9
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 77.8%
>=65 years	2 22.2%
Sex: Female, Male (Count of Participants)
Female	7 77.8%
Male	2 22.2%
Region of Enrollment (Count of Participants)
United States	9 100%

Outcome Measures

1. Primary Outcome

Title	Tumor Absorbed Dose
Description	Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.
Time Frame	up to 4 years

Outcome Measure Data

Analysis Population Description

Was only able to analyze tumor data from 3 patients based on number of tumors that could be reliably imaged for analysis.

Arm/Group Title	Patient-specific 3D-RD Dosimetry
Arm/Group Description	Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
Measure Participants	3
Measure number of tumors	5
Mean (Standard Deviation) [Gy]	6.6 (4.54)

Adverse Events

Time Frame	5 years
Arm/Group Title	Patient-specific 3D-RD Dosimetry
Arm/Group Description	Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
All Cause Mortality
	Patient-specific 3D-RD Dosimetry
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Serious Adverse Events
	Patient-specific 3D-RD Dosimetry
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Other (Not Including Serious) Adverse Events
	Patient-specific 3D-RD Dosimetry
	Affected / at Risk (%)	# Events
Total	0/3 (0%)

Limitations/Caveats

The protocol was designed for data collection with minimal impact on treatment. Data collection was terminated due to low accrual . No reportable results could be obtained.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.