The Monkey Died

[This chapter is dedicated to Sophia Kappen and Will Kays, both of whom lost their battle with cancer way too early participating in a clinical trial that they hoped would save their own life.] 

So, how about that for a chapter title?  After a somewhat circuitous journey, the title should make sense by the time I am finished. 

It’s probably about time for an update on where things stand.  A month ago yesterday, I had a hurriedly arranged surgery to place two renal stents.  This surgery was necessary due to a rapid decline in kidney function due to scar tissue that had formed in both ureters from past radiation to my pelvis and abdomen.  The adjustment to the stents has been relatively problem free so far, other than a fairly profound amount of bleeding that resulted from irritation to the ureters from the stents themselves, and the need to be on a blood thinner (i.e., Xarelto) to avoid development of blood clots – something that I have now dealt with three times in the past two years.

I read recently that cancer patients, on average, are nine times more likely to develop blood clots than people without cancer.  Nine times!  I am certainly not qualified to comment on why that is the case and quite honestly, most of the medical professionals that I have asked the question of are somewhat hard-pressed to explain it as well.  I guess we can just leave it at… for some reason, cancer patients have “stickier” blood after developing cancer.  

As mentioned above, I have lost a notable amount of blood into my urine, which has caused low red blood counts and a degree of anemia.  Because there are things coming in my near-term future that will be complicated by being on a blood thinner, I underwent a procedure this past week to place something called an “IVC filter,” which is designed to stop blood clots from breaking loose and traveling to dangerous places in the body like the lungs, heart, or brain.  Having the IVC filter will not stop blood clots from developing in the first place (I will likely still develop them from time-to-time), but the filter should keep them from becoming deadly.  By doing so, it will allow me to come off the blood thinner, which I did last week.  My blood loss is notably less than before, which should improve my red blood counts and energy level.  

I am writing this chapter from my airplane seat on my next flight to Houston to begin a week of scans and procedures at MD Anderson Cancer Center.  This is being done in anticipation of entering a Phase 1 immunotherapy clinical trial.  I have 11 events scheduled over four days.  If there is nothing disqualifying that turns up on these CT scans, MRIs, blood draws, etc., I will return next week to finalize the process of being accepted into the clinical trial, which will be a fairly invasive and time-consuming process over the next several months.

Entering a Phase I clinical trial is daunting and not for the faint of heart.  The decision process is made somewhat easier when you are running out of FDA-approved treatment options and your cancer continues to progress.  That is the crossroads where I now find myself.  A Phase I clinical trial has - as its main purpose - determining the maximum safe amount of drug that can be given to patients before they begin to experience “serious adverse events” (you know, the stuff you hear on the TV commercials that scares the **** out of you and you wonder “why would anyone take that drug?”

A Phase I trial is a “first in man” trial, meaning it is the first time that the drug, or drug combination, has been given to humans.  I have had more than one oncologist tell me that, sadly, Phase I clinical trials are not for the benefit of patients, but rather for the pharmaceutical companies conducting the trial.  But even still, there is some amount of efficacy data that can be gleaned from the trial and hopefully, as the dosage increases, some therapeutic benefit will result.

Many years ago, I proudly represented a CRO, or a “contract research organization” that does clinical research on behalf of pharmaceutical companies.  I was the Global Controller and I vividly remember my first quarter, brand new in the chair, where we met as a finance team to discuss projected financial results for the current quarter prior to meeting with our investors.  Although I was proud to be involved with a company that does clinical research, I nonetheless knew absolutely nothing about the business of clinical trials.  I think everyone can relate to being in a setting where you are completely ignorant of the topic(s) being discussed, yet also feeling the need to say something intelligent and look somewhat relevant to the process.  

I remember our Chief Financial Officer – who also happens to be a long time, dear friend of mine – laying the groundwork for disappointing quarterly financial results because one of the clinical trials for which there appeared to be great promise (and ultimately, significant revenue) – had to be cancelled.  When questioned by our CEO about what was going on with that trial, our CFO said, “the monkey died.”

As a lifelong, unabashed animal lover, I was immediately saddened by hearing that a monkey died but quite frankly, I had no idea what the **** he was talking about.  There was a palpable sense of disappointment in the room, that was no doubt a mixture of sadness for the monkey, but also for the financial repercussions of the trial being cancelled.  I held on for dear life for the rest of the meeting, desperately hoping that I did not have to make some sort of intelligent comment about the trial’s cancellation.

After the meeting, I went directly to our CFO and asked what “the monkey died” meant.  It was then that I learned that clinical trials have a preclinical phase, where a drug or drug combination is trialed before it ever gets tested on a human being.  Once safety is established in a preclinical model, it can then go into a human for the first time, in a Phase I clinical trial.  

I may soon be entering a clinical trial where a drug combination is being tested on human beings for the first time.  I know from reading the “informed consent” that a few patients (nearly 10%, in fact) in the initial dosing succumbed to the clinical trial itself, requiring a reformulation of the drug combination.  This is the current challenge and the promise of immunotherapy.  It offers such great promise for the future by figuring out how to re-arm the body’s own immune system to eradicate cancer cells, but yet do it in a way that keeps the immune system from going into full-blown, seek-and-destroy mode.  This state, known as “cytokine release syndrome,” results when the immune system gets so charged up that it also begins destroying things other than the target, including otherwise healthy tissue and organ function.  This can be a lethal reaction. 

If I qualify for the trial, I will have to sign documents acknowledging this risk.  I don’t take it lightly.  The daughter of a dear friend of mine – Sophia Kappen – died at the tender age of six years old while fighting leukemia in a CAR-T clinical trial.   Her parents did everything imaginable to fight her cancer, all to a crushing, disappointing result.

A friend of mine from Cincinnati Bell – Will Kays – died while participating in a clinical trial at MD Anderson a few years ago.  Will was the image of the high school quarterback - handsome and fit.  He had it all.  Will’s case was particularly unfortunate – he was a nonsmoker that took great care of himself and was diagnosed with advanced lung cancer.  He came to see us at Cincinnati Cancer Advisors while he was going back-and-forth to MD Anderson.  His visit to CCA rekindled our friendship from many years ago working together at Cincinnati Bell.  We were going to have lunch together after his next visit to MD Anderson.  We exchanged updated contact information and talked general timelines to get together.  We never had that lunch because he died shortly thereafter… shortly after participating in Ride Cincinnati, once again the picture of health, all while battling a deadly disease.  

These next several months will be tough.  I will try to find the humor in it all.  When I see it, you will hear about it.  I will spend longer apart from my wife, family, and my dogs than I have ever had to before.  I am sad just thinking about it, but you fight the fight in front of you when you have cancer.  This is about the closest thing to a high-stakes bet that this risk-averse, recovering accountant will ever make.  I am having to move fast… updating the last will and testament and medical directives, getting a more complicated than normal tax return filed, getting the house refinanced, explaining to Diana the ins and outs of paying the family bills, etc.  

We take for granted what goes into drug development and how many drugs on the market allow us to live a near normal life, despite otherwise debilitating or life-threatening conditions.  As much as I hate the sound of it, sometimes animals die and sometimes people with families die all in pursuit of therapies that will allow us to live better, longer lives.  My guess is that almost everyone participating in a cancer-based clinical trial is there due to some measure of desperation, but they are nonetheless people that we owe a great debt of gratitude to for helping to get us where we are today.   

Based on all of these developments, our 40th anniversary trip to France and Monaco now looks like a pipe dream, but I still look forward to returning to a life where cancer is not pummeling my body.  I think of Rocky III, where Clubber Lang (Mr. T) is kicking the living **** out of Rocky Balboa, but the fight is not over yet.  Rocky is taking the punches repeatedly in the “rope-a-dope” fashion that I mentioned in a prior chapter.  Even when it looks hopeless, you know that Rocky can still rally, and will rally.  I am by no means Rocky Balboa in this scenario, but I do know from experience that the human body can take a lot of punishment and somehow still manage to go on.  I am betting on that.  

Until next time,

Steve     

[Postscript: as I mentioned above, I wrote this chapter while on the flight to Houston.  Before the plane even landed, I received a text message from the Clinical Trial Coordinator at MD Anderson that said “Please call as soon as possible.  It’s about the financial clearance for your participation in the trial”.  The first thing I thought to myself – of course – was “Houston, we have a problem” and indeed we do.  I am waiting to see whether my insurance company will do the right thing before I write about what is going on.  Hopefully it will never come to that.  I am hoping that my insurance company will listen to some of the top genitourinary cancer specialists in the world, and that they will understand why the recommended course of treatment is necessary and will ultimately approve it.  If they don’t, the time, effort and money spent getting here will have all been a waste, and I don’t know what my remaining options are.  Stay tuned.]