Vemurafenib Neoadjuvant Trial in Locally Advanced Thyroid Cancer
brief summary
The goal of this clinical research study is to learn about how vemurafenib may affect certain biomarkers in patients with PTC. Biomarkers are in the blood/tissue and may be related to your reaction to the study drug. The safety of this drug will also be studied. Vemurafenib is designed to block the BRAF gene mutation. This mutation causes cancer and cancer growth. By blocking this mutation, the drug may kill the cancer cells with the mutation and/or stop the tumor from growing.
detailed description
Study Drug Administration and Groups:
If you are found to be eligible to take part in this study, you will take 4 tablets of vemurafenib by mouth 2 times each day for 56 days. You should take each dose about 12 hours apart. If you miss taking the drug at a scheduled time by more than 4 hours, you should skip that dose and wait until the next dose.
After 56 days, the treatment you receive will depend on what group you are assigned to:
* If the disease has spread outside the neck, you will be in Group A. * If the disease is able to be entirely removed through surgery, you will be in Group B. * If the disease is unable to be operated on, you will be in Group C.
Study Visits:
At all visits, you will be asked about any side effects you may be having and about any other drugs you may be taking.
Before you take the study drug (Baseline):
* You will have a procedure called a laryngoscopy, in which a tube with a small camera in inserted into the nose to inspect your sinus, throat, and voice box. * You will have a colonoscopy if you have a history of abnormal growth in the bowel (polyps or colon cancer). During this procedure a tube with a small camera is inserted in the anus to inspect your large bowel.
At Day 28:
* You will have a physical exam, including measurement of your vital signs. * Your performance status will be recorded. * You will have an EKG. * Blood (about 1 tablespoon) will be drawn for routine tests.
Within 1 week before Day 56, you will have CT scans of the neck, chest, and abdomen to check the status of the disease.
At Day 56, if you are in Group A or B, you will have surgery to remove the tumor. You will sign a separate consent form that describes this surgery and its risks. If you are in Group C, you will have a core biopsy. During the surgery/biopsy, blood (about 1 teaspoon) will also be collected for biomarker testing.
Follow-Up:
Your follow-up after the surgery/biopsy will depend on which study group you are in.
official title
Pharmacodynamic Study of Vemurafenib in the Neoadjuvant Setting in Patients With Locally Advanced Thyroid Cancer