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. - Full Text View

Sponsored by:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00295763

Purpose

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.

Condition	Intervention	Phase
Differentiated Thyroid Cancer	Drug: Thyrogen (thyrotropin alfa for injection)	Phase III

MedlinePlus related topics: Cancer Thyroid Cancer

Drug Information available for: Thyroid Thyrotropin alfa Thyrotropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Genzyme:

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. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To assess Thyrogen-stimulated serum Tg measurements in patients previously treated in the THYR-008-00 study. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
To assess safety information on repeat exposure to Thyrogen in patients previously treated in the THYR-008-00 study. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Enrollment:	61
Study Start Date:	May 2006
Study Completion Date:	September 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: Thyrogen (thyrotropin alfa for injection) 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295763

Locations

United States, Colorado
University of Colorado Health Sciences Centre
Aurora, Colorado, United States, 80010
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
MD Anderson Cancer Centre
Houston, Texas, United States, 77030
Canada, Ontario
LHRI Research Services
London, Ontario, Canada, N6A 4G5
France
Institut Gustave Roussy
Villejuif, France, 94805
Centre Rene Huguenin
Saint Cloud, France, 92210
Germany
University of Wurzburg
Wurzburg, Germany, 97080
Italy
University of Pisa
Pisa, Italy, 56124

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

James Magner, M.D.

Genzyme

More Information

US FDA Approved Full Prescribing Information for Thyrogen® This link exits the ClinicalTrials.gov site

Responsible Party:	Genzyme Corporation ( Medical Monitor )
Study ID Numbers:	THYR01605
Study First Received:	February 22, 2006
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00295763
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genzyme:

papillary thyroid cancer
follicular thyroid cancer
recombinant human TSH
Thyrogen

thyroid stimulating hormone
thyroid remnant ablation
radioiodine

Study placed in the following topic categories:

Adenocarcinoma, Follicular
Thyroid Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Hypothyroidism

Endocrinopathy
Thyroid cancer, follicular
Thyroid Diseases
Thyroid cancer, papillary
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009