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Square One

August 14, 2013

Monday of this week was the first day of my new clinical trial and since I have gotten a whole lot of questions about it, I thought I would share it here.

I mentioned Anti PD-1 in an earlier post but was leery to go into too much detail before the trial actually started because getting into a trial like this is often a trial in itself.  But now we are in and so I will fill you in on all the fun and gory details of how we got there.

I hear you asking “how does this clinical trial work and how do I know you aren’t going to get screwed by randomization again?”  I know you are asking that because that is the first thing my sister said.  

Take it easy, friend, here is how it works:  The study again has three arms.  It is a two drug trial–ipilumimab and novilimab.  One arm gets the novilimab, one arm gets the ipilumimab and the third arm gets both.  It is a double blinded study meaning no one knows what group I am in except a scientist in a lab somewhere far from Franklin, Tennessee.  Probably.  I don’t really know where Bristol Mayer Squibb has lab facilities.

Back to the study.  So, every participant is randomized into one of these groups, however, previous research of novilimab shows that those who took ipilumimab (ipi) before they took novilimab (novi) have a far better response than those who just got novi.  This was an incidental finding when treating melanoma patients whose disease had progressed.  Now, the drug company, 10,000 oncologists, and the FDA want to replicate those results.  SO the trial progresses as this:  If a participant has progression of disease while in the study, they can be unblinded and receive the ipi if they were not already getting it.  (Ipi has been approved by the FDA, novi has not).

One of the other big requirements of the study is that the participants had to be otherwise healthy.  I mean, except for a little cancer and all.  I fit that bill.  Pretty much.  Ask me to tell you about the two units of blood that were ordered for me from Mexico.  I fit that bill.  I am symptomatic, but my body is healthy, no cardiac problems, no brain mets, no kidney problems, otherwise healthy, just a little cancer.

We had our first infusion on Monday evening and I had some significant physical responses to the novi “dose” that make Chris and I pretty confident there was drug in that infusion.  Not so sure about the ipi “dose” but that one usually doesn’t show any symptoms until after the third dose.

The side effects we have to look forward to are pretty mild, considering.  Both drugs are Immune therapy, neither are chemotherapy agents.  The side effects look like a strong immune response–fever, fatigue, appetite loss, maybe some muscle loss, diarrhea, extreme cases a little colitis or a little pleuritis.  Both things that are very treatable and things that we can try to ward off at the pass.

If this week was any indication, I will have about 36 hours of running a low grade fever and feeling bad and then I will need a good night’s sleep.  I worked yesterday, I worked today.  I didn’t feel great yesterday, but today I mostly just feel like I need a nap.

Now if you are very clever, you noticed at the beginning that I mentioned something about Anti-PD 1.  This is the cool part.  This is the Peter Parker, Unbreakable stuff.  This is where all those dollars donated to cancer research starts to pay off in spades.  The medicine I am taking is a brand new paradigm in treating cancers.  It has only been pursued for a few years and completely flies in the face of standard chemotherapy.  If you are allergic to science, stop reading now.  Regular chemotherapy kills off as much of your immune system as it can without killing you in hopes that it can also kill off all of the cancer cells.  This therapy enhances your immune system to both recognize and destroy cancer cells through your body’s own T cells.  That is where the Anti Death comes to play.  Yes, I said Anti Death.  Doesn’t that sound cool?  One drug helps the T cells identify the cancer cells as irregular or foreign, the other drug stops an enzyme reaction in your T cells called programmed death that identifies when the T cell has accomplished enough work and destroys itself.  Now I will have bionic T cells.  They will have been treated with Anti Death.  

It is working.  There have been phenomenal results with every solid tumor cancer that has been given this therapy.  There have been EXTRAORDINARY results with melanoma.

I keep telling Chris I AM ANTI DEATH! (to be said in the voice of Batman). I am going as Anti Death for Halloween.  I just have to figure out what Anti Death looks like.  I think it looks like what I see in the mirror every morning.

Okay, this post has gotten long enough.  If you still have questions, please post them as comments either on Facebook or on the WordPress site.  Pretty much nothing is off limits.  I am a nurse, I am used to talking to people about anything.


Keep the Faith,

God’s Favorite Kid


4 Comments leave one →
  1. lbvorndran permalink
    August 15, 2013 12:40 am

    Excellent explanation. Thanks, A.D.!

    When you said “One arm gets the novilimab, one arm gets the ipilumimab and the third arm gets both,” I thought you were literally talking about arms. When we got to the third arm, I knew I needed to pay better attention.

  2. mary foley permalink
    August 15, 2013 1:56 am

    well explained and stated… love it. Love you.

  3. genna melone permalink
    August 15, 2013 4:37 am

    I think we need to make an anti- death shirt, for raising money for research, very cool, love the post. stay strong!!!! get rest!!!

  4. Kay Marshall permalink
    September 29, 2013 3:19 am

    Mareeka, My mother is entering the same clinical trial at VICC. I hope she tolerates the medicines. I continue to pray for good things to come for you and your family.

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