Drug Study to Start at Cleveland Clinic on Monday, April 20, 2015!

Well, I would lie if I didn't tell you that I finally feel at peace and excited for Todd to start the AG-221 Trial Drug Study at the Cleveland Clinic on Monday, April 20, 2015!  I have personally been so invested in getting Todd started on this drug now for months, that it looks like it is finally going to happen.  I'm so excited because I really feel like we have HOPE for Todd in taking the drug.   Where the standard of treatment available to patients like Todd, with relapsed MDS or AML, being a second transplant with a low success rate, this drug provides a new and hopefully a better option. I really believe that it is going to improve his current health and extend his life. 

There has been so much uncertainty about whether we were going to proceed with the trial study in New York at Memorial Sloan Kettering or at the Cleveland Clinic.  I have been on the phone so much the last few weeks, trying to find out our best options and to check on Cleveland Clinic's progress to get the study opened there in time to treat Todd.  He had a 28-day window to start treatment once the screening process was initiated in New York on March 24, 2015, with the deadline for starting without complete re-screening being April 21, 2015.  Unfortunately, some of the screening tests will have to redone at the Cleveland Clinic this Wednesday, April 15, namely the Echocardiogram, EKG, and blood work.  We are happy though that he will not have to repeat the bone marrow biopsy.  We have learned that each Trial Study location site has their own "IRB" or Institute Review Board, comprised of physicians and lay people, who have to review and approve all screenings, protocols, medications, and procedures to ensure safety for patients and legal and ethical parameters for the hospital/institution.  Cleveland's IRB wanted to have the above-mentioned tests redone at their location.  These tests are not invasive, so Todd did not mind repeating them for the convenience of doing the study in Cleveland. 

I was all about him going to Memorial Sloan Kettering and having Dr. Stein as his physician.  I absolutely hold both in the highest regard!  Dr. Stein and his staff are so personable and professional, that if it was my decision alone, I would go there!  However, it isn't; it is Todd's decision.  He feels most comfortable being closer to home, within driving distance, which I agree might be better in the long run.  It may mean less overnight stays. 

So, here is the run down, as far I as know right now.  We go to Cleveland Clinic tomorrow for repeat testing, to sign the consent forms, to register for the study, and to meet with his BMT doctor, who has signed-up to be a co-investigator for the study and requested to continue to be in charge of Todd's care (which we agreed to).

We will return to the Cleveland Clinic next Monday, to begin the actual study.  Depending on the "co-hort" or randomized study regimen that he is assigned to, we may have to stay for the next few days or return that week.  Some of the regimens include three days or Day -3, -2, -1 prior to treatment on Day 1.  Others start at day 1.  Of the regimens, he will likely be assigned to the Dose Escalation Phase, where he will either take the medication on an empty stomach or with food to test which works better.  He will likely be started off taking 100 mg or 150 mg twice daily.  We won't know for sure until he is registered and then assigned a co-hort. 

The drug is taken in cycles of 28 days.  Cycle 1, Day 1 protocol calls for one blood draw every hour for 10 hours along with other routine tests.  With such a long day, we will go up Sunday night so we can be at the Taussig Cancer Center at the Cleveland Clinic for the first blood draw around 7:00 a.m.!  This means the last blood draw will be at 7:00 p.m.  Depending on how we feel, we will either drive home that night or stay another night to rest up before driving the 3 1/2 hours home.  If he is assigned to the cohort that begins on a Day-3, he will do the 10 hour blood draws on that day, and then return on Day 1 to take the medication and have a different set of assessments done. 

After this, he will be given the medication to take home.  We will keep a detailed diary of his medication times and any side effects.  We will return again on Days 8, 15, and 22 for the first cycle.  On Days 8 and 22, he will only have routine blood work and assessments, so we will likely be able to drive up and back in one day.  Day 15, however, will be another one of those long 10 hour blood draw days, requiring us to likely stay overnight at least one night. 

At the end of the first Cycle, Day 28, Todd will return and complete all the same tests performed during his screening (EKG, Echo, urinalysis, bone marrow biopsy, blood work, etc.) to measure any differences the drug made, including the effect on the IDH2 gene mutations. 

I won't go into the visit requirements for future cycles, but they will be a bit less strenuous than the first month.  He will not have go in weekly, only bi-monthly, from what I understand. 

In terms of the number of cycles, that too is to be determined.  It is my understanding that in this phase the co-Horta will be at least 3 cycles.  At some point, he may have to move on and enroll in the next phase of the drug study, as they continue to test the drug's progress.  He can stay on the drug at no cost to us until the drug would be approved by the FDA and therefore would no longer be considered "experimental."  It is in the best interest of the drug company to keep Todd on the drug as long as possible, provided it is working effectively for him, with no signs of toxicity.  And of course, it would benefit him by seeing higher blood counts. 

At first, I was discouraged about how we were going to pay for our expenses going up to Cleveland, because the nurse coordinator was told that the drug company, or the Sponsor, was NOT going to pay any expenses except parking.  Sloan-Kettering's site was going to pay up to $350 reimbursement per official assessment visit and we could obtain airfare for free through the Corporate Angel Network.  However, after reading the the Informed Consent Agreement, I found a section stating that if the patient has to drive more than 50 miles one-way to the drug study site, then they will reimburse up to $250 for travel expenses per official assessment visit.  Originally, we thought they were only going to pay the $10 parking fees per visit, which would have meant we would have had to pay much more out of pocket expenses.   Keep praying that they will stick to this part of the agreement. 

Every visit, no matter how tiring for me, will be filled with positive, happy, and excited expectations!

Todd's current health
Todd had to have a transfusion Saturday, April 4, and Tiuesday, April 14, 2015; just 10 days apart.  Besides his low hemoglobin of 7.5, his other counts looked surprisingly better:  Whites .7, Platelets 51,000, and Neutrophils at .4.  While these are by no means great or anywhere near normal, they are a slight improvement from the CBCs of the last few weeks; so we will rejoice all the same!  I think these counts are up because he hasn't had any chemo drugs for 8 weeks.  While the chemo kills the blast cells, it also kills what little he has of his healthy cells.  This is good, but now the blast cells are increasing unhindered which is bad.  The drug, which has been shown to work in as little as one cycle, will help block the IDH2 mutations which allows more cells to mature and fully develop into healthy cells, thereby decreasing the number that turn into blast cells. 

He gets increasingly tired and light-headed as the number of days after his transfusion increase.  His spirits are good, and even feels up to harassing me with silly jokes most of the time!

Family matters
Wow!  Things have been crazy busy!  It always is the last quarter of school.   Ellie is finishing up Club volleyball season and started running track to stay in shape. Hannah Lewis is preparing for Prom, and helped to host the High School senior portfolio art show. The art projects she completed as a result of her Yeck Art Scholarship at the Dayton Art Institute will be on display at another art show there on May 28. I'm a bit behind, but we are preparing for graduation May 30. I need to get announcements printed and out in the mail, then prepare for a graduation party.  A great offer came in from the Columbus College of Art of Design  and we are trying to steer Hannah Lewis in that direction because of its proximity and because it provides the lowest financial committment (debt).  Abby is finishing classes at the University of Cincinnati and needs to move out of her dorm room by the first weekend of May. She needs your prayers as she considers whether to stay at UC or transfer to Wright State University in the fall, so she can be nearer to home with everything going on.  She is going to try to take a math class over the summer at Clark State, which is close to home. 

We also need prayer and any suggestions or connections for Abby and Hannah Lewis to get summer jobs.  They both have been applying for jobs, but haven't been able to secure anything yet.  Hannah Lewis is only 17 and that disqualifies her from many opportunities for 18 year old mandated positions.  Abby is looking for a serving position at a nicer restaurant, but is open to other jobs. 

Financially, we are happy to finally receive the first Social Security Disability payment this month!  We have been preparing our house to put up for sale by the end of the April or beginning of May. The real estate market in Beavercreek, Ohio has been hot!  So, we want to maximize what we can get out of it. Looking for the right size house has been a bit of  challenging. We know we need to sacrifice, but looking at something a fourth of the size of our house has been shocking for us and a bit saddening for Ellie. Our current home is really the only house she has known.  While Todd and I are more ready for going smaller, Ellie wants a bit of personal  space (aka a teenage retreat away from mom and dad but under the same roof!).   We also want to have space for Abby and Hannah Lewis if they want to come back home for summers, holidays, and/or if they want to transfer to a local school. 

I haven't been able to work much and I spend a lot of time on the phone arranging for Todd's treatment. I applied for 1 summer class and 1 workshop, both of which are short and all online. I also applied for two summer internships, but haven't heard back. I think once Todd is down to bi-monthly visits and hopefully needs less transfusions, I can start working. My parents, family, and friends have offered to go with Todd for his treatments, so I can find a job or internship. 

I have to work 150 paid or unpaid hours for my practicum to be able to graduate by the end of the year. I originally planned on doing a practicum in the fall at Wright State University, but their digital archives department is no longer accepting practicum students. So, I have until June 8, to find and register for a different practicum.  Paid would be nice, but I'm just anxious to gain the job experience. It's very complicated, but I need a few things to come together for my last class and practicum in the fall to graduate. 

Thanks again to those of our supporters who are still sending gas cards, meals, and financial gifts. We will be putting out a call to action soon asking for help with a very projects around the house, packing, moving, and maybe some help painting walls if we buy something else that needs it! 

Thanks for all your love and support.