Status:
COMPLETED
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.
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Differentiated Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 hav...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00295763
Start Date
May 1 2006
End Date
September 1 2006
Last Update
March 18 2015
Active Locations (9)
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1
University of Colorado Health Sciences Centre
Aurora, Colorado, United States, 80010
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
3
Ohio State University
Columbus, Ohio, United States, 43210
4
MD Anderson Cancer Centre
Houston, Texas, United States, 77030