Drug Study @ Cleveland Clinic begins April 13, 2015

The beginning of the week has been a pretty good one for Todd.  On Monday, he went into see the local oncologist and to get his weekly CBC.  He did not need a transfusion, with his Hemoglobin at 8.5 and Platelets at 56,000.  His whites and ANCs were still dangerously low.  The only concern the doctor discussed with Todd that day was about removing his Hickman central catheter, fearing a greater potential for developing an infection with it in.  While we know this, we have always taken great care of it and have never experienced any problems with it.

We are not sure it was a good time to remove it just yet.  Although the drug in study, AG221, is a pill, they will still need to hourly blood draws for 10 hours on certain days, which means ten less arm sticks!  In addition, it makes it easier to get transfusions and weekly CBCs. 

Dr. Stein from Memorial Sloan Kettering called us early Monday morning to me answering in a craggy voice!  I had been suffering from sinus drainage and had almost lost my voice.  He was concerned about Todd, but I assured him that Todd was fine!  He said he had spoke to the Drug Company representatives who are setting up the trials and that they thought Cleveland might be ready in a week or two.  He asked us to call our contacts at Cleveland to see how the process was going and when they expected to start.  Todd told him we would call and get back to him.  Todd called BMT doctor and left a message.  We didn't hear back until after 5:00 pm that evening.  She said she was trying to find out who the site investigator was and would get back to us.  By late Tuesday afternoon, I still hadn't hear back from the BMT doctor.  I called Dr. Stein and told him that we still hadn't heard anything from Cleveland.  He found out who the site investigator was in the course of our conversation and said he would send him a message.  Later that evening, the BMT called saying they were anticipating a department meeting on April 10 and then they would be up and running and able to start the drug study on April 13, 2015, if there were no problems.  I relayed the message back to Dr. Stein's office and I asked about Todd's bone marrow biopsy results, but they were not back yet. 

Todd was a bit anxious to hear about his biopsy results, and we finally heard back from Dr. Stein today with his results and we formulated a plan for beginning the trial study.  First, the results:  the bone marrow biopsy done in New York, as part of the screening process, showed that his blast cells had increased slightly to 5-8%.  This was up some from his biopsy on February 18, 2015, when they were at 3%.   We had expected this slight increase since Todd hasn't had any chemo since February.  Once again, we were pleased that the count was not higher. 

Second, we talked to Dr. Stein and received multiple messages from Todd's BMT doctor in Cleveland in regards to enrolling in the AG221 drug study at Cleveland Clinic beginning April 13, 2015.  Dr. Stein was good with us switching locations and actually wanted us to do what would be easiest for us.  They only real concern was getting the screening results and records transferred to Cleveland and actually being able to start the trial at Cleveland ON TIME. 

The main concern at this point is the window of time Todd has open to get started on the drug.  We only have 28 days from the screening date of March 24 until Todd starts the drug without having to re-do all the screening tests, which would be too much on Todd.  So, that gives us until April 21, 2015, as the deadline for Todd to begin taking the drug.  Todd's BMT doctor said she would out of town next week, but that she would have the trial study contact nurse stay in touch with us next week to let us know if everything was still on schedule, or if there are any problems.  The drug company is to do an inspection and final approval on April 10. His BMT doctor asked us how soon we could get a flight to New York through The Corporate Angel Network, in the event that there would be a complication, and the drug study start date would get pushed back at Cleveland.  In that case, we would have to go back to Memorial Sloan Kettering in New York to begin the first month of the study there. 

In a way, we are still in limbo about where we need to go for the study.  If, everything goes according to schedule, Todd will start the study at the Cleveland Clinic on April 13, 2015.  If there is a problem, and Todd can't start the study at Cleveland that week, then we will be returning to New York (likely on April 20, 2015). 

Several people have expressed their concerns about Todd returning to Cleveland, since we LOVE Memorial Sloan Kettering and can't praise Dr. Stein enough.  Of course, we would rather see Dr. Stein and go to MSK, but Todd feels the traveling to New York and back so much that first month would be very taxing.  I think driving to Cleveland three and half hours each way is more taxing than flying and driving in, but going to New York might require more overnight stays than Cleveland.  This would be harder on the family in general too. I like Cleveland Clinic; they have been very good to us, don't get me wrong, but I really like Dr. Stein and Memorial Sloan Kettering.

If you have ever noticed, that up until this point, I have not used any of Todd's doctors' names just to be sensitive regarding anything negative I may say.  Dr. Eytan Stein, however, I have introduced you to through the many articles and presentation he has done via posts on my blog in the past.  It would have been hard to conceal his name, knowing the work he has done with this trial drug study.  I'm so happy that I have nothing say but GOOD about him!  This is the kind of doctor you thank God for.  I believe that he serves God by serving mankind.  You can tell he has a servant's heart with compassion for his patients and their families.

Todd's BMT doctor feels we should wait on getting rid of his Hickman catheter just yet.  Once the trial gets started, we are going to re-visit the issue and there is a good chance that they will remove the Hickman and put in a port for the blood draws.  This would require a lot less care (no daily flushing and weekly cap and dressing changes done by me) and it would be more comfortable for Todd in general. With it in, he can't get it wet not has he been able to sleep on his stomach since he had it put in last year.  It would also take away an avenue for an infection to get in.    

Tomorrow, Todd goes in to Miami Valley to see the Respiratory Therapist to get a breathing treatment of his Pentamidine. He may also go to the Cancer Center to have his blood counts checked to see if he needs a transfusion.  Then, we are all going to our first all-family counseling session.  I'm not sure if I like the psychologist just yet; time will tell.

I have spent most of this week cleaning up and decluttering the house, so we can get ready to put it on the market.  I've also started typing up a selling sheet, as we intend to list our house for sale by owner. Please be in prayer for this entire process.  It is stressful and a bit sad to know how much of our belongings will have be sold.  I need to also plan a garage sale soon, so I can thin out the garages and some smaller items in the house.  Truth be told, I will likely have to have a moving sale too, after we sell. 

We are looking forward to spending Easter with our children and my parents. May God bless you as you celebrate Christ's Resurrection! And, to my Jewish friends, I wish a Blessed Passover. Thanking God for his grace day by day. 

Appointment at Memorial Sloan Kettering

There is so much to say I don't know where to start and what to include in this post. 

First, I need to give a shout-out to The Corporate Angel Network. I can't say enough good things about our experience so far. I spent time on the phone last week coordinating the appointment, securing a hotel, and waiting to hear about flights. 

We got the call Thursday that they got us a flight into Terboro Airport, NJ leaving out of Columbus, OH. They arranged for a car to pick us up at the airport and drive us to our hotel into New York City. We had to pay for the trip/car but it was so nice to let an experienced driver navigate the narrow lanes, traffic jams, constant honking, and aggressive drivers. 

On Friday,March 20, 2015 we got a call that the Angel network had secured us a flight back on Tuesday morning, March 24, and a free shuttle ride back to the airport. We would only have to pay a cab to get us to the shuttle location before 7 am. The flight would return back to Columbus so we would be able to drive ourselves to the airport and leave our car. 

Meanwhile, in Dayton they wanted to  give him IV antibiotics for seven days so they had to schedule around our trip 

We arrived an hour early to the independent Flight company an hour early. It was so nice not to have to go through security, put our liquids in small bottles, and be exposed to all the people at a public airport. The pilots were so nice and made us feel welcome. The  company members, whose flight we were on with, were so gracious and hospitable to us. The flight from Columbus only took 1 hour!  We landed and our car arrived shortly and took us to our hotel, The Bently, in the upper east side of Manhattan, which is only four short blocks from the hospital. We didn't have time to go to get food at a restaurant, so we grabbed a bite at the hospital's cafeteria. The appointment was at 2:00 pm. 

The space inside the hospital was very tight, which makes sense for a prime real estate area in New York. The staff were all extremely friendly and accommodating. I also liked their policy of asking everyone to wear masks, including family members in the Cancer office waiting rooms. They also provide rubber gloves for patients who don't want to touch anything. 

We didn't have to wait long to see Dr. Stein. He wasn't anything like I thought he would be. He was short, friendly, personable, honest, and straight-forward. He asked Todd to recount his medical history from the time of diagnosis in October 2011 to present. Then he gave us the opportunity to ask questions, which I had a list of!  

I started with asking him about his opinion to do a second transplant or not. He said it doesn't matter whether to do the second transplant now or in the future. He felt that Todd would still have the same results. He asked us if we were aware of second transplant outcomes. I said yes, they weren't good. He said that's right. According to the published reports, second transplants have a success rate of 5% to 10% and he felt those numbers were generous. 

I asked if Todd would be a good candidate then for the study and he said so far everything looked good. I also asked if there would be a better study out there besides this one, and he said no.  For Todd's MDS with the IDH2 gene mutation, this was the right one. 

We asked if we could start the study here and then transfer to another closer study location and he said yes. According to his sources, Cleveland might be up and running by mid-April at best. 

I asked if the drug was working for him, could he stay on it indefinitely and he said yes. They would continue to administer it to him throughout the additional phases of the study as long as there were no complications or adverse events (AE). Todd could continue transfusions and his current medications without any restrictions. 

When I asked about how often we would need to return for testing throughout the study, his answer surprised me; it was a bit more often than I had anticipated. The first month, we would be required to be present once a week. After that, every 15 days or twice per month. Testing on days 1 and 16 the first month would be the most intense with testing lasting 10 hours each day. He advised us to be prepared to stay an extra day afterwards to have some recovery time before flying home. 

When I asked the most important question: What could we expect from the drug that would help Todd and how soon he could start it, he began by saying that they are not sure how sustainable the response would  be. They hadn't got that far along yet in the studies.  So far, they have had patients still having positive results for as long as 14 months. He was clear to say that the drug should not be considered "curative."  He said the goals he would like to achieve in Todd's case would be to get his counts high enough to get him off of transfusions and to get his white count up past the point of being neutropenic. Blast counts at this point wasn't considered a major issue, since they were already low at 3%. The good news is that the drug can create healthy neutrophils from the blast cells, because it allows them to mature. 

He was very frank with us when I asked him what his opinion was regarding Todd's prognosis. Todd's BMT doctor just danced around the issue, and we wanted to know the truth. He regretted to tell us that relapsing within the 100 day period post-bone marrow transplant was detrimental and that Todd's only real hope for a curative treatment was the transplant. I cried and said why didn't the transplant work!  Everything was ideal going into it. I said I wish we hadn't done the transplant and it only seemed to make things worse. He assured us that we did the right thing in pursuing the transplant. There was no doubt in his mind that he would have recommended the transplant too, even if it was for a family member; he would have done the same thing.   It's so frustrating and hard not to ask WHY???

I asked him what was the difference  between staying on monthly rounds of Vidaza or doing the trial drug. He said that after looking at Todd's blood work, it didn't look like the Vidaza was really working. His platelets have come up but his other counts are still down. He also asked us if we know how sustainable Vidaza is, and we acknowledged that there would likely be a point where he would no longer respond to Vidaza. He agreed. In all fairness though, I had learned that it takes 4-6 cycles of Vidaza to reap the best benefits and Todd only had 3. 

With Todd's MDS, his blast counts have never been out of control or escalated to AML (>20%), but that's not what is affecting Todd's condition. Right now it's the low blood counts, especially his low white and neutrophil counts. This puts him at such a high risk of infection. As a matter of fact, he put it bluntly that for most patients in Todd's condition, infection is the most likely cause of death. The doctors are doing what they can to prevent this scenario by giving him antibiotics and antiviral medication. Monitoring his temperature is crucial. It is often the first sign of infection. If caught early, they can treat it more effectively. 

As to the costs, we are responsible for the preliminary screening, which our insurance should cover. Once he has been deemed eligible for the study, the drug company will pay for tests and treatments associated with the trial. In addition, they will help out with travel expenses up to a certain amount. 

So far there are at least 73 patients currently on the drug officially. It is a pill taken usually once or twice a day. We will be notified what amount and dosage Todd will take. When I asked about side effects he said that there have been some. Mainly an increase in bilirubin, but no major complaints of nausea or diarrhea. Among the AEs there have been some concerns with heart and lung problems. 

This is why they run all of the baseline tests: to establish how his organs are prior to the study and if there are any significant changes that could be caused from the drug. 

We asked how soon Todd could enroll and he said it takes about a week to sign, screen, and receive eligibility status. We asked if we could start by signing the consents that day, but he said no. Apparently, you can't see the doctor and sign the consents the same day. (Might look like Coercion). He asked if we could stay another day or two so we could get everything started while we were already here. We said we thought it could be arranged if they could do everything tomorrow. So his staff began to see if they could get all the necessary tests scheduled for the next day, while I called The Corporate Angel Network to switch our flight, and the hotel to see if we could stay another night. They got everything scheduled and so did we. I called my mom and asked if she minded to stay another day-it was fine. 

Before we left the hospital they needed to do a finger stick to collect a little blood to check his counts. Then he had to have a chest X-ray to look at his Hickman catheter. This protocol has to be done since Todd's Hickman was not put-in by Memorial Sloan Kettering. They have to ensure that it was done right and looked good before they are allowed to draw blood from it. 

It was rush hour when we left. We walked back to the hotel and Todd put on his PJs and took a nap. I eventually joined him. We napped until about 9:00 pm. We were too tired to go out so we ordered a true New York style Margherita pizza and had it delivered to our room. It was delicious. We watched a bit of TV and I flushed his lines and worked on the blog. We were looking forward to sleeping in, getting a hot shower, and getting a good breakfast since we didn't need to be at the hospital until 12:00 noon. 

In closing, We were sad to hear that our hopes for a curative second transplant were confirmed: not to pursue it because the rate of success would be very low. We were encouraged that we could start the process of getting enrolled so soon. Although the drug is not considered curative, we have hope that Todd will see an improvement in his counts and hopefully have more energy, and a better quality of life. There is still so much they don't know about the sustainability of the drug, or how long it will work, but we feel this is the best option for now. There is always hope that it will work for a long time, or long enough until another cure or newer treatment becomes available. 

I keep telling myself that miracles happen everyday!  It could happen for Todd. Thanks for your continued prayer and support. God is still in control of the big picture.