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.
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.
|Differentiated Thyroid Cancer||Drug: Thyrogen (thyrotropin alfa for injection)||Phase 3|
|Study Design:||Allocation: Randomized
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.|
- 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 ]
|Study Start Date:||May 2006|
|Study Completion Date:||September 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295763
|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|
|LHRI Research Services|
|London, Ontario, Canada, N6A 4G5|
|Centre Rene Huguenin|
|Saint Cloud, France, 92210|
|Institut Gustave Roussy|
|Villejuif, France, 94805|
|University of Wurzburg|
|Wurzburg, Germany, 97080|
|University of Pisa|
|Pisa, Italy, 56124|
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|