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A New Study to Follow-up Thyroid Cancer Patients Who Participated in a Previous Study, Which Compared the Success of Destruction of the Thyroid Remnant Using Standard Treatment or Thyrogen.

Primary Purpose

Differentiated Thyroid Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Thyrogen (thyrotropin alfa for injection)
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Differentiated Thyroid Cancer focused on measuring papillary thyroid cancer, follicular thyroid cancer, recombinant human TSH, Thyrogen, thyroid stimulating hormone, thyroid remnant ablation, radioiodine

Eligibility Criteria

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

Inclusion Criteria: Committed to follow the protocol requirements, as evidenced by providing written informed consent before any study-related procedures are performed and within 28 days prior to Day 1; Completed the THYR-008-00 study; A negative serum pregnancy test within 8 days prior to the start of the week during which the patient will receive Thyrogen and radioiodine (required for all pre-menopausal women of child bearing potential, with menopause defined as age >50 years with >2 years without a menstrual period) Exclusion Criteria: Patients who are currently taking amiodarone or other prescribed iodine-containing medication; Patients who received iodine-containing X-ray contrast material within the prior 3 months; Women of child-bearing potential, unless confirmed to have a negative pregnancy test prior to dosing; Women who are pregnant or lactating; Patients who are currently participating in another investigational drug study or who have participated in such a study within 30 days of their enrollment in this study; Patients with schedule or travel plans that prevent the completion of all required visits; The patient who by mistake received only one-half the intended dose of Thyrogen during THYR-008-00 (Patient 209); The patient in THYR-008-00 who was found to have lung metastases on her post therapy scan (Patient 204); A concurrent major medical disorder (e.g., documented significant cardiac disease, debilitating cardiopulmonary disease, advanced renal failure, advanced liver disease, advanced pulmonary disease, or advanced cerebral vascular disorder) that may have an impact on the capability of the patient to adequately comply with the requirements of this study.

Sites / Locations

  • University of Colorado Health Sciences Centre
  • Johns Hopkins University
  • Ohio State University
  • MD Anderson Cancer Centre
  • LHRI Research Services
  • Centre Rene Huguenin
  • Institut Gustave Roussy
  • University of Wurzburg
  • University of Pisa

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

To confirm the status of thyroid remnant ablation by using Thyrogen stimulated radioiodine whole body scans (WBS) in patients previously treated in THYR-008-00.
To learn if there was recurrence of thyroid cancer in any of the patients previously treated in the THYR-008-00 study.
To assess Thyrogen-stimulated serum Tg measurements in patients previously treated in the THYR-008-00 study.
To assess safety information on repeat exposure to Thyrogen in patients previously treated in the THYR-008-00 study.

Secondary Outcome Measures

Full Information

First Posted
February 22, 2006
Last Updated
March 17, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00295763
Brief Title
A New Study to Follow-up Thyroid Cancer Patients Who Participated in a Previous Study, Which Compared the Success of Destruction of the Thyroid Remnant Using Standard Treatment or Thyrogen.
Official Title
Follow-up of Thyroid Cancer Patients From Study THYR-008-00 Who Received Thyroid Remnant Ablation Using Either the Hypothyroid or the Thyrogen Method.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

Brief Summary
Patients diagnosed with thyroid cancer are commonly treated with surgery to remove their thyroid gland followed by radioiodine ablation to destroy any remaining parts of the thyroid gland that may have been missed during surgery. It is thought that ablation with radioiodine destroys normal remaining thyroid tissue as well as cancerous cells either in the thyroid area or at other sites. Following successful treatment, patients are then monitored by their physicians at regular intervals with testing to detect any recurrence of thyroid cancer throughout the body. If thyroid cells are detected by these follow up tests, the physician will decide the best method to re-treat the patient. In 2001-2003 Genzyme conducted a clinical study to test if Thyrogen® can be used to accomplish radioiodine ablation treatment. This study aimed to determine that the success rates of radioiodine ablation were comparable when patients were prepared for ablation with Thyrogen® while being maintained on their normal thyroid hormone therapy, or, alternatively, by thyroid hormone withdrawal. Thyroid hormone withdrawal commonly causes uncomfortable side effects for patients, and these might be avoided by the use of Thyrogen. Eight months after the initial Thyrogen plus radioiodine treatment to achieve ablation, all patients in both groups were given Thyrogen® to test for any remaining thyroid tissue. The results of this testing showed that all patients (in both groups) had successfully achieved remnant ablation and had no detectable thyroid tissue remaining. In order to confirm these remnant ablation results we will conduct follow up testing in this study for all patients that were enrolled in the previous study and we also will determine if their thyroid cancer has recurred. Only patients who completed this previous Thyrogen ablation study are eligible for entry into this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Differentiated Thyroid Cancer
Keywords
papillary thyroid cancer, follicular thyroid cancer, recombinant human TSH, Thyrogen, thyroid stimulating hormone, thyroid remnant ablation, radioiodine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Thyrogen (thyrotropin alfa for injection)
Intervention Description
No reference therapy was given. All patients in this follow-up study received Thyrogen. Thyrogen 0.9 mg was administered intramuscularly (IM) in the buttock on 2 consecutive days. For WBS and static neck imaging, each patient received 4 mCi (148 MBq) ± 0.4 mCi 131I PO.
Primary Outcome Measure Information:
Title
To confirm the status of thyroid remnant ablation by using Thyrogen stimulated radioiodine whole body scans (WBS) in patients previously treated in THYR-008-00.
Time Frame
Duration of study
Title
To learn if there was recurrence of thyroid cancer in any of the patients previously treated in the THYR-008-00 study.
Time Frame
Duration of study
Title
To assess Thyrogen-stimulated serum Tg measurements in patients previously treated in the THYR-008-00 study.
Time Frame
Duration of study
Title
To assess safety information on repeat exposure to Thyrogen in patients previously treated in the THYR-008-00 study.
Time Frame
Duration of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Committed to follow the protocol requirements, as evidenced by providing written informed consent before any study-related procedures are performed and within 28 days prior to Day 1; Completed the THYR-008-00 study; A negative serum pregnancy test within 8 days prior to the start of the week during which the patient will receive Thyrogen and radioiodine (required for all pre-menopausal women of child bearing potential, with menopause defined as age >50 years with >2 years without a menstrual period) Exclusion Criteria: Patients who are currently taking amiodarone or other prescribed iodine-containing medication; Patients who received iodine-containing X-ray contrast material within the prior 3 months; Women of child-bearing potential, unless confirmed to have a negative pregnancy test prior to dosing; Women who are pregnant or lactating; Patients who are currently participating in another investigational drug study or who have participated in such a study within 30 days of their enrollment in this study; Patients with schedule or travel plans that prevent the completion of all required visits; The patient who by mistake received only one-half the intended dose of Thyrogen during THYR-008-00 (Patient 209); The patient in THYR-008-00 who was found to have lung metastases on her post therapy scan (Patient 204); A concurrent major medical disorder (e.g., documented significant cardiac disease, debilitating cardiopulmonary disease, advanced renal failure, advanced liver disease, advanced pulmonary disease, or advanced cerebral vascular disorder) that may have an impact on the capability of the patient to adequately comply with the requirements of this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
University of Colorado Health Sciences Centre
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
MD Anderson Cancer Centre
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
LHRI Research Services
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
University of Wurzburg
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
University of Pisa
City
Pisa
ZIP/Postal Code
56124
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19850694
Citation
Elisei R, Schlumberger M, Driedger A, Reiners C, Kloos RT, Sherman SI, Haugen B, Corone C, Molinaro E, Grasso L, Leboulleux S, Rachinsky I, Luster M, Lassmann M, Busaidy NL, Wahl RL, Pacini F, Cho SY, Magner J, Pinchera A, Ladenson PW. Follow-up of low-risk differentiated thyroid cancer patients who underwent radioiodine ablation of postsurgical thyroid remnants after either recombinant human thyrotropin or thyroid hormone withdrawal. J Clin Endocrinol Metab. 2009 Nov;94(11):4171-9. doi: 10.1210/jc.2009-0869. Epub 2009 Oct 22.
Results Reference
derived

Learn more about this trial

A New Study to Follow-up Thyroid Cancer Patients Who Participated in a Previous Study, Which Compared the Success of Destruction of the Thyroid Remnant Using Standard Treatment or Thyrogen.

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