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.

• ClinicalTrials.gov Identifier: NCT00295763
• Recruitment Status: Completed
• First Posted: February 24, 2006
• Last Update Posted: March 18, 2015
• Sponsor: Genzyme, a Sanofi Company
• Information provided by: Sanofi

Tracking Information

• First Submitted Date: February 22, 2006
• First Posted Date: February 24, 2006
• Last Update Posted Date: March 18, 2015
• Study Start Date: May 2006
• Actual Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 20, 2008)

• 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 ]
• 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 ]
• To assess Thyrogen-stimulated serum Tg measurements in patients previously treated in the THYR-008-00 study. [ Time Frame: Duration of study ]
• To assess safety information on repeat exposure to Thyrogen in patients previously treated in the THYR-008-00 study. [ Time Frame: Duration of study ]

• Original Primary Outcome Measures (submitted: February 22, 2006): 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.
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Differentiated Thyroid Cancer

Intervention

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.

Study Arms

1

Intervention: Drug: Thyrogen (thyrotropin alfa for injection)

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 22, 2006): 61
• Original Enrollment: Same as current
• Actual Study Completion Date: September 2006
• Actual Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, France, Germany, Italy, United States

Administrative Information

• NCT Number: NCT00295763
• Other Study ID Numbers: THYR01605
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Medical Monitor, Genzyme Corporation
• Original Responsible Party: Not Provided
• Current Study Sponsor: Genzyme, a Sanofi Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Genzyme, a Sanofi Company

• PRS Account: Sanofi
• Verification Date: March 2015