Monday, March 29, 2021

2nd Clinical Trial at NIH

It's official!

I have been enrolled as patient #4 in the NIH clinical trial for PRGN-2012 and will begin in May.  If this is the cure for RRP, not only will it be life-altering for me, but it will pave the way for all others after me.  

Sunday, March 7, 2021

The most difficult month of my life

This is the second part of the saga, where for a 10-day period, we weren't sure how long I had to live.  

When we last left off, my oncologist at University of Minnesota had performed a flow cytometry which resulted in ruling out leukemia.  They speculated that the interferon medication which I take for my recurrent respiratory papillomatosis had inexplicably reduced my white and red blood counts and my platelets.  So we planned to skip two more interferon treatments and test my blood again with expectation that my counts would rebound to their normal baselines.  

The CBC results on Tuesday, February 23rd did not show any improvement.  So the next step was to see a hematologist as soon as possible.  There was something causing my anemia and thrombocytopenia and my oncologist wanted to get the expert opinion of someone who specializes in diseases of the blood and blood components.  

Two days later I was back at University of Minnesota.  It was now Thursday, February 25th.  

My hematologist informed me that on the latest blood analysis, there were 15% of "other" cells appearing in the manual differential.  The "other" were classified as abnormal lymphocytes, which are immature forms of the cells which get released from the bone marrow into the circulation.  If 20% or more of the blood cells in your bone marrow are immature, you may be diagnosed with Acute Myeloid Leukemia (AML).  Treatment for AML involves multiple rounds of intensive chemotherapy.  It may go to into remission, but there is a chance it returns and while further chemotherapy treatment is possible, it likely will not be effective.  At that point, options are reduced to stem cell (bone marrow) transplant or clinical trials.  

Patients with the most lethal form of AML typically survive for only four to six months after diagnosis, even with aggressive chemotherapy.  The 5-year survival rate for people 20 and older with AML is about 25%.   I was within 5% of the level in which AML is diagnosed.  

Earlier results showed some levels of abnormal cells -- this is why the flow cytometry was performed in the first place.  But this was the first time that they showed up in this measurable amount.  To confirm the suspicious of AML, the next step was to conduct a bone marrow biopsy. 

After getting the news, I was frozen with fear. Before leaving the hospital I had to sit down as I needed a minute for everything to sink in.  I sat there for a solid 20 minutes before I was able to go to the parking lot and drive home.    

Six (long) days later I was back at University of Minnesota.  It was now Wednesday March 3rd. 

Bone marrow has a fluid portion and a more solid portion. In bone marrow aspiration, a needle is used to withdraw a sample of the fluid portion. In bone marrow biopsy, a needle is used to withdraw a sample of the solid portion.  The bone marrow fluid and tissue sample are usually collected from the top ridge of the back of a hipbone.  They first start by numbing the area, then they make a small incision in the skin of your lower back and insert a hollow needle through the outer bone into the marrow to collect the liquid, then a larger needle is used to collect a sample of the tissue.  Since I am young(er) and a (former) runner, my bones were very hard.  

With a lot of pressure to puncture the outer bone, the solid portion of the marrow was extracted.  However, when they performed the aspiration, it resulted in a "dry tap" which means they were unable to get any liquid out.  They tried several times in different places but were unsuccessful  A dry tap occurs only about 3% of the time, of which 92% of the time results in some form of pathology, which could be leukemia  So here I was, still days away from having the formal results, and we were already trending the wrong direction.  Fortunately, they were able to extra enough solid portion for the analysis. 

The procedure only took about an hour and I liken it to getting a tattoo where you are filled with adrenaline that eventually wears off and you crash.  For the next 36 hours it felt like I had a spike in my lower back.  When Rachel changed the dressing she said that it looked like I had a hole drilled into my back.  The hematologist said that it could take three to five days for result to come back.  More waiting.

We did have some positive news that came from the CBC which was performed before biopsy.  My lymphocytes were back up and my blood showed no "other" cells.  My basophils, eosinophils, monocytes and neutrophils were all in the low range of normal.  My platelets were at 105, which was a major improvement from the 86 they were at back on February 2nd when this whole ordeal began.  And my RBC was 4.06 -- still below the normal range but up from 3.6 a month earlier.  We tried to reserve our judgement until the biopsy results came in, but with no "other" cells showing up, maybe leukemia would once again be off the table. 

On Friday, March 5th we heading south in the late afternoon, driving toward Des Moines, Iowa where we were going to pick up our new beagle puppy early the next morning.  It was the 22nd anniversary of the day I left Michigan Tech as a electrical engineering graduate.  We had Fiina and Luna in the back of the Rover with us.  While listening to the Cubs preseason game against the Cleveland Indians, I saw a notification on my phone from the University of Minnesota medical app.  With a deep breath, I picked up my phone and opened the message. 

You know how there are some moments in your life that you will never forget where you were when you got certain news?  This was one of them.  We were in Story City, Iowa.  How fitting.

Bone marrow, left posterior iliac crest, decalcified trephine biopsy, aspirate clot, touch imprint, and peripheral blood smear shows nincrease in myeloid blastsno abnormal myeloid blast, no aberrant immunophenotype on T cells, no morphologic or immunophenotypic evidence of hematolymphoid neoplasm with rare lymphoid aggregates, not diagnostic of lymphoma

It's not leukemia.  For the 2nd time. 

I handed the phone to Rachel for her to read the results and confirm.  It's not leukemia.  While I still wanted to be able to read the results again for myself, we both took a deep sigh of relief.  A little while later while at a rest stop, my hematologist called to confirm that the biopsy and aspiration looked normal.  She still did not know what caused the abnormal counts and appearance of immature cells, but it definitely was not a result of AML.  

We can positively, definitely say, without a shadow of a doubt, I do not have leukemia at this very moment in time.  Apparently I just had to drive to Iowa to find out. 

All of my doctors (my hematologist, my oncologist, my endocrinologist and my otolaryngologist) will meet early next week, but they all believe that this was caused by my continued use of interferon.  Since interferon alfa is a type of targeted cancer drug, patients usually don't take it for extended periods of time (like I have).  So the long term effects aren't really known.

So what is next?  If this was caused by my interferon, which I need for my RRP, does that mean we go back to having surgery every 6 weeks?  We certainly hope not.  I should find out in the next week if I am eligible for another clinical trial at NIH with Dr. Clint Allen.  As part of the trial, I would have to stop taking interferon anyway, and travel to Bethesda, MD where a trial vaccine would be administered.  We are hopeful that this is the answer, the cure, and we won't ever have to take interferon ever again.  

We thought that we might be writing the epilogue of my life story, but it turns out there are still many more chapters to be written.  

My wife Rachel has stood with me from the very beginning.  Even when faced with the worst, she said that we would face it together.  I will never be alone in this fight, no matter what comes next. 

You shoot me down but I won't fall, I am titanium.