Papillary Thyroid Carcinoma Clinical Trial
Official title:
Re-differentiation of Radioiodine-Refractory BRAF V600E-mutant Papillary Thyroid Carcinoma With GSK2118436
Radioactive iodine therapy is often part of the standard treatment for Papillary Thyroid
Carcinoma (PTC) patients. However, in many patients, tumors develop a resistance or no
longer respond to radioactive iodine therapy (iodine-refractory). Several lines of evidence
suggest that blocking the BRAF gene may help to re-sensitize the tumors to radioactive
iodine. BRAF is a protein that plays a central role in the growth and survival of cancer
cells in some types of PTC. The investigational drug GSK2118436 may work by blocking the
BRAF protein in cancer cells lines and tumors that have a mutated BRAF gene.
In this research study, the investigators are looking to see if GSK2118436 can re-sensitize
iodine-refractory PTC to radioactive iodine therapy. The investigators are also looking at
the safety of adding GSK2118436 to radioactive iodine therapy.
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
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06399159 -
Prediction of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma Based on Ultrasound and Cytological Images
|
||
Recruiting |
NCT04336696 -
Is Routine Dissection of Central Lymph Node Necessary for Papillary Thyroid Carcinoma, T1-2 N0?
|
N/A | |
Not yet recruiting |
NCT06261190 -
Active Surveillance for Low-risk Papillary Thyroid Carcinoma
|
||
Recruiting |
NCT05263141 -
Retro-Auricular Single-Site Endoscopic to Papillary Thyroid Carcinoma
|
N/A | |
Recruiting |
NCT05932121 -
Cross-sectional Case and Control Study on Quality of Life, Appearance and Functions in PTC Via Different Surgical Approach
|
||
Recruiting |
NCT02814032 -
Proteomics of Papillary Thyroid Carcinoma
|
||
Recruiting |
NCT01417442 -
BRAF V600E Mutations In Papillary Thyroid Carcinoma
|
Phase 0 | |
Completed |
NCT01311089 -
A Comparative Study of Robotic Thyroidectomy Using Transaxillary Approach Versus Conventional Open Thyroidectomy
|
N/A | |
Recruiting |
NCT03411187 -
Study on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy
|
N/A | |
Recruiting |
NCT05760690 -
Safety of Endoscopic Thyroidectomy Via Retro-Auricular Single-Site Approach, Transoral Approach and Transareola
|
N/A | |
Recruiting |
NCT04624477 -
Active Surveillance and Surgery Outcomes in Low Risk Papillary Thyroid Cancer
|
||
Completed |
NCT02323724 -
APPLICATION OF MOLECULAR TECHNIQUES FOR IMPROVING THE DIAGNOSIS AND TREATMENT OF NODULAR THYROID LESIONS.
|
N/A | |
Recruiting |
NCT05962892 -
A Study of Factors Influencing Recurrence After Thermal Ablation of Papillary Thyroid Carcinoma
|
||
Recruiting |
NCT03454477 -
Comparison Between Robotic, Endoscopic and Traditional Open Surgery in Thyroidectomy
|
N/A | |
Completed |
NCT02561533 -
Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma
|
N/A | |
Active, not recruiting |
NCT04197960 -
Microwave Ablation and Surgical Resection for Micropapillary Thyroid Carcinoma
|
N/A | |
Completed |
NCT01354639 -
Comparative Study of Surgical Completeness After Robotic Thyroidectomy Versus Conventional Open Thyroidectomy
|
N/A |