Vemurafenib Trial for Advanced Thyroid Cancer Before Surgery

Program Overview

The purpose of this study is to understand how vemurafenib, a drug designed to block a cancer-causing gene mutation, affects certain markers in the blood and tissue of patients with papillary thyroid cancer (PTC). The study will also assess the safety of vemurafenib. By blocking the BRAF gene mutation, vemurafenib may help kill cancer cells or stop tumors from growing.

Description

If you qualify for this study, you will take vemurafenib tablets twice a day for 56 days. After this period, your treatment will depend on your cancer's status:

• Group A: If the cancer has spread beyond the neck.
• Group B: If the cancer can be completely removed by surgery.
• Group C: If the cancer cannot be operated on.

Study Visits:

• Before starting the drug, you'll have a laryngoscopy to check your throat and a colonoscopy if you have a history of bowel issues.
• On Day 28, you'll have a physical exam, an EKG, and blood tests.
• Before Day 56, you'll have CT scans to check the cancer's status.
• On Day 56, if you're in Group A or B, you'll have surgery to remove the tumor. If you're in Group C, you'll have a biopsy.

Follow-Up:

• Groups A and C: After surgery or biopsy, you'll have regular check-ups every 4 weeks, including physical exams, blood tests, and CT scans every 8 weeks.
• Group B: You'll have follow-up visits 2 and 8 weeks after surgery, with the option to continue vemurafenib if beneficial.

Length of Study:

• Group A or C: Continue vemurafenib as long as beneficial.
• Group B: Take vemurafenib for 56 days, then stop after surgery.

End-of-Study:

• After stopping vemurafenib, you'll have a final visit or call to discuss any side effects.

This study is investigational for thyroid cancer, though vemurafenib is approved for late-stage melanoma. Up to 22 patients will participate at MD Anderson.

Eligibility Criteria

Locations