Thursday, June 27, 2013

Clinical Trial Beginnings

Hi everyone!

Sorry for the delay in updates lately.  Returning back to work, catching up with friends, and simply living life really kept me busy, and I've enjoyed every minute.  My appointment last week, which included having CT scans and lab work done, was pretty emotional for my family and me.  We found out that the Yervoy has not had any delayed effects on my cancer and the scans showed growth -- But the doctors did emphasize that the good news in all of this is that the cancer had not spread to anywhere else in my body!  The scariest part was the doctors weren't sure what the next steps would be in my treatment since we have now tried the two top choices for treatment with no luck of shrinking the tumors.

The options presented to us were to go with the old school treatment of chemotherapy (IL-2) or attempt to get me into one of the melanoma clinical trials with new drugs.  The chemotherapy route would mean having an inpatient treatment, and the side effects I've heard people have from the IL-2 are very extreme.  Not to mention the chemo is not known to be very effective treating melanoma.  So, I definitely wanted to go with a clinical trial and get the opportunity to  receive the latest drugs being developed to treat advanced stage melanoma.

I received the call last Friday that there was an opening in a clinical trial that I qualified for at Moffitt.  The clinical trial is a combination of LGX818 and MEK162.  These two drugs are so new they do not even have names yet (hence the three letter/three number identifiers).  The trial is in phase II which means they have found the tolerated maximum dosage in phase I.  This is my first clinical trial, and I'm learning just how extreme this experience is going to be -- especially after today.

Today was my initial screening, which is required to start the clinical trial.  I started the day meeting with the trial coordinator to sign my consent forms to begin this craziness.  These clinical trials want to track everything about your health, so they scheduled me for a full day of tests, scans, and biopsies.  Talk about a fun day :/

Luckily my CT scans were recent enough that I got to skip repeating those, but I had blood work done in the morning, an ECG, a MUGA scan, a skin biopsy, and a needle biopsy to finish the day off.  The MUGA scan and ECG made sure my heart was healthy enough to be in the trial.  The samples of my skin and part of the tumors were needed for baseline study as well.  I couldn't be happier that this day of feeling like a lab rat is finally over.

As long as all my tests come back showing I'm healthy enough to begin the trial, I will go in on Monday, July 1st to receive my first doses of the drugs.  I'll have to spend the whole day at Moffitt in the Clinical Research Unit (CRU) after taking this initial dose of the drugs so the doctors can take blood samples every hour to see how my body is responding.  This first month I'll be spending at least one day a week at the CRU.  Each month is considered a cycle, and they say the first three cycles will be the most time consuming with appointments where they run all the tests to track how these drugs are working.

So, I'm going to do my best to keep everyone up to date as I go through this next phase in my treatment.  Unfortunately, the main side effects of these drugs are extreme sun sensitivity -- so I won't be able to be out in the sun for any extended amount of time. No beach days for me :(  But if that is the only side effect I have, I'll be very grateful!

After this emotional week, I'm excited to be going to Disney with my mom to have a weekend away before starting the treatment Monday.  I hope everyone has a great weekend!