Yesterday, we went through the (mostly) last hoops to jump through before beginning a clinical trial of a two-drug combination. I will try to keep this as simple as possible, not for your benefit, but for mine, because I really suck at science!
The trial (hereafter referred to as Super Soldier Serum 2, or SSS-2) is designed to check the effectiveness of two drugs working together; Nivolumab (Nivo), and Ipililumab (Ipi). Ipi is an FDA-approved drug for treating melanoma. If this sounds like a familiar scenario, it is, because the IL-2 treatment I had at U of M a couple summers ago was also a melanoma treatment. It turns out that kidney cancer (RCC) and melanoma are pretty closely related. Nivo is not FDA approved for anything, yet. It's been through trials on melanoma, RCC, and a few other things. This stage of the Nivo/Ipi trial builds on an earlier stage. In that part, they paired Nivo with a couple of different drugs to see what it did to my kind of cancer. The drug that it did the best with was Ipi, by far. So now, the trial is looking a different dosages to see what works best... and what is safe enough to use. The trial has three different groups of patients: One that gets a lot of Nivo, and a little Ipi; One that gets a little Nivo, and a lot of Ipi; and one that gets a lot of both!
These two drugs work, as Dr. Rini explained, by taking the brakes off of your immune system. In the vernacular of my students, my immune response will "go ham," constantly attacking the cancer cells, but also by way of collateral damage, attacking some of the rest of my body. Most of the side effects come from this attack, lots of "-itis" things, with inflammation of joints, muscles, bone, stomach, etc. Also, for the benefit of Elizabeth, it appears I will have "manageable" diarrhea. What that means, I have no idea. Extreme fatigue is anticipated. J'fatigue! J'fatigue! Je suis tres fatigue! The doc and Nurse Laura say that I should be able to work, but I'm gonna be pretty wiped out by it.
Things are going to move very quickly, beginning miraculously (and I definitely mean that in the Hand of God at work sense) the week after the marathon. The Wednesday after, I go in for last-minute tests, and signing the big packet of releases and waivers that come with a drug trial. Then the real fun begins. The trial has two phases, induction, and maintenance. In the induction phase, I'll get both drugs administered over the course of two infusions in a very long day. The first infusion will be Valentine's Day - which is the 18th anniversary of my first date with Katie, 16th anniversary of our engagement! Then I go back the next week to get checked out to make sure I'm tolerating it OK, again the week after that to see how we're tolerating, and then the third week I go back for the next infusion. We repeat that cycle two more times, for a total of four infusions of the combination drug. April 18 will be the last with the combination of drugs. It should also be the end of the worst of the side effects. Twice in that period we will have CT scans to see what's happening with the lung tumors. The early results have been very promising. In a study of the same two drugs used against melanoma, 50% of patients saw shrinkage of 80% or better of tumors, and the side effects were reversible.
After that, we drop the Ipi, but stay on the Nivo... in perpetuity. This is the part of the trial I am most nervous about, simply because of the time and distance commitment. Every other Friday, I'll be driving out to Cleveland in the afternoon to get infused with Nivo. I'm very, very, very much hoping we can schedule it in such a way that I miss my afternoon classes, but can work the half day in the morning to try to preserve my days. I gain one sick day every three weeks, and if I can keep this down to using 7-10 full days, and then burn 1.5 sick days every 6 weeks while earning 2, I think I will be OK. I am also counting on Ingrid (my '96 Volvo) being up to the challenge of some wonderful adventures on the Ohio Turnpike! We're also waiting to find out how all of this will work with insurance. The drugs are covered by the drugmaker, and things that are specifically study-specific are covered by the drugmaker, and that's an absolute godsend!!! But things like the infusion time and crapload of CT scans will be billed to insurance. If insurance covers this all as standard of care, it'll be much better, but it pretty much guarantees we'll hit deductible every year, which has become a much bigger deal over the past eight years of budget issues. The logistical headaches of cancer sometimes dwarf the physical headaches of treatment!
We thank all of you for your thoughts, prayers, and support. From my biological family, through my first friends in Grand Rapids, to my SJ guys, to the old West Hall gang, the Fort Wayne friends, our adoptive Bowling Green & St Al's family, and especially my students and colleagues from Rogers, I know that the power of prayer and positive energy is what's gotten us this far. This cancer has a 5-year survival rate of 8 percent; the median patient with metastatic disease makes it nine months. We're just at the edge of three years, and doing pretty damned well, all things considered. Medically, we are in the best possible situation we could have dreamed of; SSS-2 is the best possible treatment for this stage of disease, and we're incredibly lucky that Cleveland Clinic happens to be the locus of the study instead of Mayo, MD Anderson, or someplace else that would be infinitely more difficult to pull off financially! Having pretty much THE world expert on kidney cancer just 100 miles from home... and being able to consider him a friend, as well as a doctor, is a gift that I am well aware few people get. I think often of how blessed we have been every step of the way.
OK, that's the last I talk about the trial for the next 10 days. Now, 100% of our focus is on the Winter Soldier Marathon next weekend! Plans are solidifying like the ice on the Maumee for the run, which has grown into proportions I never dreamed of. When Dr. Rini said he was going to run with us, he asked if it was OK to share the info with their PR department, to include a picture in the Clinic's internal newsletter. When PR got a hold of the story, they asked him (and me) if it was OK to pitch the story elsewhere, and it looks like this Sunday's Plain Dealer, and Monday's Blade will have articles about the run! Katie or I will post links as soon as we get them.
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