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Follow-up of Thyroid Cancer Patients From Study THYR-008-00 Who Received Thyroid Remnant Ablation Using Either the Hypothyroid or the Thyrogen Method.


Phase 3
18 Years
N/A
Not Enrolling
Both
Differentiated Thyroid Cancer

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Trial Information

Follow-up of Thyroid Cancer Patients From Study THYR-008-00 Who Received Thyroid Remnant Ablation Using Either the Hypothyroid or the Thyrogen Method.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

Duration of study

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

THYR01605

NCT ID:

NCT00295763

Start Date:

May 2006

Completion Date:

September 2006

Related Keywords:

  • Differentiated Thyroid Cancer
  • papillary thyroid cancer
  • follicular thyroid cancer
  • recombinant human TSH
  • Thyrogen
  • thyroid stimulating hormone
  • thyroid remnant ablation
  • radioiodine
  • Thyroid Neoplasms
  • Thyroid Diseases

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Ohio State UniversityColumbus, Ohio  43210
University of Colorado Health Sciences CentreAurora, Colorado  80010
MD Anderson Cancer CentreHouston, Texas  77030