Fortunately for Team Studzinski, Dr. Flaherty is the principal investigator for a new research study sponsored by Hoffmann-La Roche. 135 patients will be selected to test the efficacy of Vemurafenib in treating metastatic melanoma that has spread to the brain. Remember, Vemurafenib is the new melanoma drug that received FDA approval last August.
Enrollment criteria:
- Metastatic melanoma spread to the brain
- Melanoma cells have BRAF V600 mutation
- Present in 50% of melanoma patients, this mutation disrupts the body’s ability to control how cancer cells grow, allowing them to rapidly divide and multiply.
- Vemurafenib works by blocking the effects of the BRAF mutation
- Complete various tests and screenings
- Various signatures and approvals
Over the last few weeks, Dr. Flaherty's clinical research team has been working to enroll me as a participant as I am the perfect candidate. I clearly meet Criterion #1 and my first tumor tested BRAF positive. Done deal, right? Not exactly.
Criterion #2 proved to be a challenge as the cross section of the tumor specimen tested in August did not meet study requirements. Karmanos discovered they did not have a large enough sample from my second tumor, so they had to contact Beaumont to retrieve the appropriate cross-section from my first tumor. The sample arrived to the designated lab in Nevada on February 7th for testing. We heard BRAF positive confirmation on February 15th, the lab had a 7-10 day backlog. The timing of our Arizona vacation couldn’t have been more perfect!
Now onto Criterion #3. The tests and screenings are required to establish a baseline used to identify the presence and severity of Vemurafenib’s potential side effects (like every other drug, the list is lengthy).
Criterion #2 proved to be a challenge as the cross section of the tumor specimen tested in August did not meet study requirements. Karmanos discovered they did not have a large enough sample from my second tumor, so they had to contact Beaumont to retrieve the appropriate cross-section from my first tumor. The sample arrived to the designated lab in Nevada on February 7th for testing. We heard BRAF positive confirmation on February 15th, the lab had a 7-10 day backlog. The timing of our Arizona vacation couldn’t have been more perfect!
Now onto Criterion #3. The tests and screenings are required to establish a baseline used to identify the presence and severity of Vemurafenib’s potential side effects (like every other drug, the list is lengthy).
- Skin exam (2/16): check for presence of cutaneous squamous cell carcinoma (SCC), it manifests itself in 25-33% of patients.
- Pelvic/Abdomen/Chest scans (2/20): check for presence of subcutaneous SCC
- Electro Cardiogram (2/20): some patients experience a prolongation of the QTc interval in their heart cycle
- Blood work (2/20): establish bilirubin baseline as there is potential for injury or damage to the liver or liver cells (indicated by increased amounts of bilirubin in the blood)
Other potential side effects include:
- Common: fatigue, nausea, diarrhea, increased bilirubin in the blood, rash, SCC, scaly skin, itching, hives, hair loss, sensitive to light, sunburn, dry skin, joint/muscle pain, tingling/burning of hands and feet, loss of appetite, weight loss, headache, change in sense of taste
- Rare: basal cell carcinoma, hand/foot skin reaction, pancreatitis, eye inflammation, kidney failure, difficulty swallowing, arthritis
I am set to go to Karmanos Monday morning for the tests indicated above and a meeting with Dr. Flaherty and his research team. While I had originally expected to walk out with Vemurafenib, we got a call late Friday afternoon informing us that they do not have all the required signatures. I paged Dr. Flaherty and he promised to try and remedy this first thing Monday morning.
Stay tuned!
Hope all goes well with your testing tomorrow! I'll say a prayer for you!
ReplyDeleteDonna M.