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.

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00295763
First received: February 22, 2006
Last updated: August 3, 2009
Last verified: July 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

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
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: 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
Centre Rene Huguenin
Saint Cloud, France, 92210
Institut Gustave Roussy
Villejuif, France, 94805
Germany
University of Wurzburg
Wurzburg, Germany, 97080
Italy
University of Pisa
Pisa, Italy, 56124
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided by Genzyme, a Sanofi Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00295763     History of Changes
Other Study ID Numbers: THYR01605
Study First Received: February 22, 2006
Last Updated: August 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme, a Sanofi Company:
papillary thyroid cancer
follicular thyroid cancer
recombinant human TSH
Thyrogen
thyroid stimulating hormone
thyroid remnant ablation
radioiodine

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

ClinicalTrials.gov processed this record on October 29, 2014