20 days into the Ariad trial

Can't believe it's already been 20 days on the new trial drug. I am doing some day round trips to Portland, and I have to say that I am getting way to familiar with the route. Come December, I will only have once a week appointments, and half of those can be done at Seattle, so I know there is light in the end of the tunnel.

My BP has been very stable around 130/80 for the last 4 times, so I think the stress is off there. Today's CBC showed whites at 3.2k, platelets at 66k, and Neutraphil at 54%. In english, the only number to be a little concerned about is the platelets, since if it drops below 50k, then I may have to have a short vacation off the drug, or lower dosage. This is not abnormal for these types of drugs, in fact, on Sprycel I hit 44k on Sprycel. As for the whites, it went up to 3.9 last week, but now back to 3.2. These numbers will swing +/- 100's, even within the same day, so it's nothing to worry about. as long as I don't see higher than say 10k, I should be comfortable with the white number.

This week has another round trip to Portland on Wednesday.

14 days into Ariad trial

On the side effect front, none to minimal. Had some muscle ache last weekend, but it was just a few hours over a couple of days. Someone else had reported similar side effects.

 

Friday's appointment included an Echo-Cardiogram. If you've never seen one of these, it's basically like a sonogram of a baby, but instead they are looking at your heart, each individual chamber as well as the valves. It's pretty fascinating to lay there watching your heart beat, and see the flow of blood going through each chamber. Things looked normal per the technition, but of course a specialist has to view the results.

 

On the CBC (Complete Blood Count), my whites have been 3.9k all week (fairly stable), but my Platelets dropped to 77k on Friday. We covered on Tuesday what would happen if they drop below the 50k mark, which is a lower limit of being on the trial. Dr. D would either lower my dosage for a short period, or give me a drug vacation. I think between the two, I would probably prefer a lower dosage, since I know people getting as low as 15mg are getting a response, and I am on 60 mg.

 

This coming week is a Monday/Wednesday appoitment, in which I will do the down and back each day. The road to Portland is definately turning into the road most travelled these days, but the prospect of being able to come home to Cynthia and the kids each day, is worth the drive alone. Come 2nd week of December, it's a weekly appointment, with every other week being possible to be done in Seattle.

7 days into Ariad trial

While I was hoping this past week would be less stressful than the previous week, unfortunately it was not so. I got a call from our friend Leif on Friday, that one of the greats, Scott Lui had passed away. Some may know that Scott had battled CF his whole life, and at the age of 32 had a double lung transplant that gave him another 5 years. He was truly one of a kind, and we all will miss him greatly., The trial let me head home to be with the soccer team Friday night, and we cancelled our game and instead met at the Roanoke Tavern to share friendship and some good Scott stories. The one thing that will always resonate with me, is that how graceful and bravely Scott approach his disease, and he learned quickly in life that time and friends are precious and that you attack each day with a zest for life. He leaves a giant hole in our hearts, and our thoughts and prayers go out to Kristen and his twin girls Ruby and Stella that are left behind. Scott really was a gift to everyone who had the luck of crossing paths with him.

 

On the trial side of things, it's becoming a little more routine. I think we figured out the BP problem, it turns out that my BP is 12-20 points lower when taken manually than compared to the Blue Octopus. The nurse did a very thorough experiment this morning, measuring multiple times, and we came to the conclusion that I'm a manual kind of guy going forward. It seems that side effects of some early headaches are going away, so if this is the worst of it on the drug, I'm doing good. (Knock...knock)....Today Nancy is my nurse again for my all day testing, she is wonderful and besides the fact that I have an IV in my arm to simplify blood draws, it's really not that bad.

 

I’m off to lunch, due to not being able to eat +/- 2 hours of the trial drug, my breakfast got screwed up so I am starving...

Day 2 in Ariad trial

This morning was just a quick 30 min appointment, check vitals (still high BP), draw blood, and then take my medicine. I don't really get results or anything, and the way the meds work,, we won't really be looking at my blood counts until probably next week when I see the Dr. again. These daily visits are just with the clinical study coordinator and a nurse. The staff is just wonderful, and even after just a couple of days, I feel that I'm seing friends each day.

 

No side effects yet, so hopefully that stays. The possible side effects are headaches, skin rash, and some blurring of th eyes. Of course everyone reacts differently. The dr's thought is that more people on Sprycel experience the low blood count numbers, compared to this drug, so we shall see...Everything is going to plan, so just taking one day at a time...The only real bummer is that they want me to stay down here this weekend, but possibly home next weekend.

 

Thanks for all the well wishes and e-mails. It's been really nice to pull my computer and hear from everyone. It really made yesterday's experience so much better.

Much to catch up on

So much has happened in the past week that I have to start at middle of next week, and go forward. I had left last entry that we were waiting on Insurance coverage to come through, and it got interesting from there.

Middle of last week, we got a preliminary denial from the insurance company, which at the time didn't seem to unreasonable given that we know that they do not cover Phase 1 trial drugs. We were told by OHSU that it is unfortunately common, and usually approved upon peer review. So my dr. at OHSU was going to talk to the medical director of my insurance company, Friday morning. As luck had it, it was the same time that I was scheduled for a transplant consultation at SCCA. This is being done to make sure that we proceed as far as possible with planning for the transplant, without actually doing one. The whole idea of the drug trial, is to hopefully finally get the results we are looking for from a single pill a day.

Cynthia had her blackberry with her into the meeting, and we knew an e-mail would be forthcoming. Towards the end of the meeting, we received word that we had been denied, even after the peer review. I think OHSU was simply floored, they had not experienced this before, and my participation was at risk to say the least. Literally when we walked out of the SCCA meeting, I was resigned that I was 3-4 weeks away from a transplant.

Now Cynthia has a more assertive approach to these things than me, and after some deliberation, we decided to reach out to OHSU and see if we could still enroll in the study, and pay our portion that the trial wouldn’t cover. We didn’t know the exact costs, but we knew that if we didn’t enroll on Friday, we would miss the window and have to possibly wait 1 more month, which did not seem like a good idea given that I am on no drugs at all….

OHSU did a quick check, and said that would be fine. Although I would need to get down to OHSU that afternoon, since there is a consent form that had to be signed in person with the Dr. he was going to be out of town the following week, so we looked at each other, and simply pointed the car south. We made Portland in a little more than 3 hours, which on a Friday afternoon is a small miracle.

When we got back, we knew that we had bought us some time. We were told there were other appeals avenues, but the problem we had was that I had to be enrolled on Friday, or wait. I reached out to a former manager at MS, who put me in touch with a Director in HR. I know realize how huge that was, since while we were sitting at OHSU on Monday, the nurse popped her head in and said that it was now approved and they were getting it in writing from the insurance company. I literally felt my shoulders drop 2 inches, due to the stress we were under.

So Monday turned out to be an all day screening day. Besides a blood pressure issue, I did very well, and the team understands that it’s stress/anxiety induced, but we are closely monitoring it.

 So today (Wednesday) I am literally sitting in the recliner at OHSU, with an IV hooked up to my arm so that they can take blood without poking me with another needle. I took my first dosage of 60 mg at 9:10, and I am getting blood draws very frequently. The last one today will be at 5:10.

I think in the last week, I lived through every possible roller coaster experience I could imagine. Through this all, I can’t express how much Cynthia has done, and made me able to do. I find that I lean on her more and more, since when it becomes overwhelming, she has the ability to see things clearer. We also have had incredible help from her mother and Aunt to help with the kids while I’m out of town.

Right now, it looks that I will be calling my address Portland for at least 10 days. I can’t go home this weekend which is a bummer, but I did bring my golf clubs, and my newly acquired Big Bertha driver from Brian. I plan to vent any frustrations over the past week, on some innocent range balls…

10 days off Sprcel

October 26

Oct 28th - 10 days off Sprycel and other updates

Being off Sprycel was kind of the reverse of going on the drug in the first place. Some mild headaches, that easily went away with Tylenol. Once through that, I am feeling better, and my weekly checkup numbers have shown that my White Count has increased slightly from 2.2k to 2.8k, and my platelets have gone up from 44k to 58k. My hemoglobin has also gone from 9.7 to 11.3, which is correlating to more energy.

 

On a different note, our friends gave us an absolute wonderful weekend. Between babysitting, bringing food, watching the kids so that Cynthia could finish up a project in the house, and a great round of golf, it was a very good weekend. Christian especially loved the sitters, he asked me today 'where are the guys' ?

 

So Plan A is still the drug study at OHSU. Hopefully we sorted out some insurance questions today, I've been told that I may start as early as this week. I'm eagerly awaiting a start date, we're ready to get going on this study. My numbers are slowly going up, so we're not greatly concerned, but I feel somewhat unprotected not taking any drugs. But with the T315 mutation, I know now that none of the existing meds would do anything for me long term.

 

On another note, during my blood draw today, Dr. P stuck his head in (I was only supposed to see the nurse), and he said "you better be nice to Tanya" ...it really caught me off guard, since I wasn't expecting to hear anything yet. While there is another test they do, he is pretty confident that she is a 10/10 match for me. We haven't heard back from Kristine yet, but having just one of them being a great match, is grealy comforting. I knew I had a good chance to find a good match on the registry, but of course a sibling match is ideal. Transplant is still Plan B, but it's nice to know that I have Tanya as a good match for me.

 

Smoking gun

One of the hardest things for me has been not able to explain what the heck is going on. I 'failed' Gleevec with no mutations found, and then I am having little effect with Sprycel. It's been extremely frustrating to not be able to explain what was going on. I have asked myself countless times, would I be better off going the transplant route, rather than the Ariad study, since we had no documented evidence that Ariad would be able to help me. I suppose because of that situation, starting the process of preparing for a transplant has been easy to accept, since I have no idea of what Ariad could do for me.

 

On Monday, I got a call from Dr. P, and he left me a message that he would try to reach me that afternoon. I’ve come to learn when a Dr. calls you and leaves a message with no content, it’s never good news. I learned that from my day of diagnosis, when my dr. asked me to come back the following day. I’ve also correlated the seriousness of the news with being able to discuss over the phone, or have to go in person.

 

He called back a little while later, and the news he had was related to my mutation report. For those who may remember, a mutation report was done back in June after failing Gleevec, and no mutations were found. This time, it came back and it showed that I have the infamous T315I mutation, which is known to resist both Gleevec and Sprycel (and Tasignia as well).  This is probably the most known mutation of CML, since it’s documented for quite some time, and no drug to date has managed to show good results against it.

 

Now we know why my CBC’s were very good, but my Cytogenetics were not improving. As Sprycel/Gleevec were killing off the non-mutated leukemia cells, they were being replaced by the T315I cells which the drug was not able to latch on to. This resulted in over time the percentage of T315I cells becoming more than 20% of the overall number of stem cells (which is when they typically show up in a mutation study). This replacement of bad with worse cells has been happening over time.

 

This helps address a nagging question, would increase dosage of Gleevec worked for me, would increased dosage of Sprycel do the trick, or switching to Tasignia ? The answer for all is no. It’s clinically shown that none of those will address the T315I mutation. In fact, without Ariad, there would only be one option on the table, a Bone Marrow Transplant.

 

So, in a way, this is good news. I am hesitant to share too much about other people’s result on Ariad and T315I, but it’s safe to say that I am now a better fit for Ariad than I was before, since that drug is designed to tackle the T315I mutation as its primary objective, among others. In fact, the press release in July calls out the effectiveness on that mutation.

 

So I remain cautiously optimistic, I have been told that they should be enrolling me no later than the end of this month. SCCA and OHSU is coordinating my treatment, and I just learned today that they want me to discontinue Sprycel to allow my numbers to rebound before starting the new drug. It does mean a month in Portland, so I’m reading myself on all levels to be down there and focus on what I need to do. Now it’s game on, we know within 3-4 months, there will either be good news on Ariad, or transplant will be the plan of record.

 

Thanks again to Mandy/Tyler, Amy and Beth and Bobby who have been a wealth of information and someone to lean on. My aunts have also as usual been able to provide encouragement and support that only they seem able to do.