Re-differentiation of Radioiodine-Refractory BRAF V600E-mutant Papillary Thyroid Carcinoma With GSK2118436
You will take GSK2118436 capsules by mouth for 28 straight days. If your Day 28 whole body
radioactive iodine scan demonstrates significant uptake of iodine, you will take GSK2118436
for an additional 14 days (Days 29-42). You will be given a drug diary to record when you
take GSK2118436. This diary will also contain instructions on how to take GSK2118436.
Prior to Day 1
- Optional fine needle aspirate (pre-treatment) Day 1
- Vital signs
- Routine blood tests (2 tablespoons)
- Research blood sample for Circulating Tumor Cells (CTCs). (4 teaspoons of blood)
- Optional research blood sample for CTCs 4-6 hours after the first dose of GSK2118436
Day 2:
- Optional research blood sample for CTCs 4-6 hours after the first dose of GSK2118436
Day 3-5: Research blood sample for CTCs Days 8 and 15
- Vital signs
- Routine blood tests (2 tablespoons)
- Research blood sample for CTCs. (4 teaspoons of blood)
- Optional fine needle aspirate (Day 15 only) Low Iodine Diet: You will begin a low
iodine diet on Day 15, in preparation for Day 23 when you will receive radioactive
iodine (131I). The study team will provide you with instructions on this diet. The low
iodine diet will be continued until the whole body scan is complete. For those
participants who will receive a therapeutic dose of radioactive iodine on Day 37, the
low iodine diet will be continued until the Day 42 whole body scan is complete.
Days 21 and 22: The drug thyrogen will be administered as in injection into your buttocks on
Days 21 and 22 in preparation for your whole body radioactive iodine scan on Day 28.
Thyrogen is used as a diagnostic tool to help determine the status of your cancer and is
approved for use in thyroid cancer patients.
Day 23: To prepare for the whole body radioactive iodine scan, you will be asked to swallow
a capsule of radioactive iodine which will be absorbed by any remaining thyroid cells in
your body. Radioactive iodine is approved for use in thyroid cancer patients. You will then
be asked to return for the scan on Day 28.You will be asked to sign a separate consent for
the radioactive iodine.
Days 1-28:
- Optional repeat fine needle aspirate Day 28
- Whole body radioactive iodine scan to assess your thyroid cancer
If your Day 28 whole body radioactive iodine scan demonstrates significant uptake of iodine,
you will have the following tests done within 24 hours:
- Vital signs
- Routine blood tests (2 tablespoons)
- Research blood sample for CTCs. (4 teaspoons of blood)
- An injection of a therapeutic dose of radioactive iodine will be administered. If your
Day 28 whole body radioactive iodine scan does not demonstrate significant uptake of
iodine, you will be removed from the research study. You will have a 3 month follow up
appointment as outlined below.
If your Day 28 whole body radioactive iodine scan demonstrates significant uptake of iodine,
you will continue treatment with GSK2118436 and have the following study visits:
Days 35 and 36: The drug thyrogen will be administered as in injection into your buttocks on
Days 35 and 36 in preparation for your whole body radioactive iodine scan on Day 42.
Day 37: You will be given a therapeutic dose of radioactive iodine. You will be given a
separate consent form to sign for your radioactive iodine treatment. You will then be asked
to return for the whole body radioactive iodine scan on Day 42.
Day 39:
- Vital signs
- Routine blood tests (1 tablespoon)
Day 42:
- Whole body radioactive iodine scan
- Research blood sample for CTCs. (4 teaspoons of blood)
After the final dose of the study drug: All participants will have a follow up visit 3
months after you stop the study drug. You will have the following tests at this visit:
- Routine blood tests (2 tablespoons)
- Research blood sample for CTCs. (4 teaspoons of blood)
- An assessment of your tumor by CT scan or PET/CT scan of your neck, chest, abdomen and
pelvis.
- Those participants who had a therapeutic dose of radioactive iodine on Day 37 will have
a whole body radioactive iodine scan.
- Optional fine needle aspirate
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Radioiodine Uptake
To explore the hypothesis that treatment with GSK2118436 in patients with radioiodine-refractory metastatic BRAF V600E-mutant PTC will lead to increased radioiodine uptake in their disease sites (all patients).
2 years
No
Stephen M Rothenberg, MD, PhD
Principal Investigator
Massachusetts General Hospital
United States: Food and Drug Administration
11-337
NCT01534897
July 2012
May 2014
Name | Location |
---|---|
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |