05/15/10- Released for Good Behavior

After 5 days in La Jolla being poked, prodded and receiving treatments, we are finally back home. On day 3 I received the second drug in the trial called Bendamustine (Treanda) and the trial drug, called ABT-263 which is oral. There had been a lot of talk about this drug tasting horrible, but it is less than a teaspoon, they give it to you in a syringe that you squirt down your throat and then chase it with juice, or iced tea. It actually wasn't that bad, tasted something like burned peanut oil. Now how in the world would I know that? Ever seen me cook? They have to do blood tests every hour to check how your body is reacting to the drug, and they do this for 8 hours. The side effects were very mild, didn't sleep at night (but I think it was because of the steroids they gave me with the Bendamustine), little upset stomach the next day, but overall nothing I couldn't deal with. One of the major side effects of the trial drug is that it drops your platelets and raises your liver enzymes. It was quite a shock on Friday when I got the report. Platelets went from 222,000 on Thursday to 144,000 on Friday (normal range is 150-300). Even though it is a huge drop, it is not anything that could take me out of the trial. They have to go below about 25,000 to do that. I felt well enough to go out to dinner (Osteria Romantica in La Jolla, thanks Kevin) with Bruce and Connie who happened to be in the area yesterday.

This morning I had my blood draw after we checked out from the hotel, started driving home and got the call that my platelets had dropped down to 121,000, but that was still OK. So, I took the 3^rd and last dose on the way home. The original plan was for me to have a blood test on Sunday and Monday in La Jolla, but I convinced them that I could get them a reliable sample up here (am going to LB Memorial), and that way I don't have to drive down there for a 5 minute blood draw. Since I had my last dose, there is really nothing to be done now except to wait until my next round in June. If my platelets are at a worrisome level, then they will postpone, or stop, but I don't see that happening.

So the new plan is now to get my blood drawn up here Sunday and Monday, go back to La Jolla on Tuesday for my monthly IVIG, another blood test, a physical exam, an EKG and an echocardiogram. Then I have to get blood tests every Tuesday until June 8^th, when I begin the second round.

SHINGLES. I want to put in a little info on my bout with shingles. First off, I am not a medical professional and no one should do anything without talking to their health care professional. I had a diagnosed case of shingles (without the red rash and blistering, which is not common, but does occur). The pain is difficult to describe. It is kind of a burning / stabbing pain. In my case it went in about a 5 " band from my belly button on my right side to my spine. Shingles usually happens on just one side at a time. I think because I was on anti-virals already, it may be kept me from getting the rash. But what I was left with I would not wish on anyone. I have been in almost constant discomfort for 3 weeks. Nothing even touched it except Tylenol w/ codeine and that wasn't very much. Now that I am on the trial I can't take aspirin, Tylenol, any Nsaids (like Motrin), so I am left to just grin and bear it. Today is the first day that I have periods when I don't feel it. There is possible help for 'normal' people (those without compromised immune systems). There is a 'shingles vaccine' that you can get from your doctor. If you have a chance to get it, then by all means, do it. I couldn't have had it because it is a 'live' virus and I can't have any of those, but most other people can. So ask your doctor and take the vaccine. End of my non-medical advice.

I actually feel pretty good, a little tired, some mild GI issues, but I still have an appetite. Now with another 20 days to recover, I would expect that I will be just fine for the next round. The success of this treatment will depend on how my White count responds (downward), keeping my hemoglobin up, and keeping my platelets and liver enzymes at good levels. In order to get a decent response I will have to have at least 5 more rounds of treatment and maybe up to 7. So we take it one day at a time.

Terry

05/12/10 - Start of Treatment

On Tuesday I began my Clinical Trial. They take it slow for the first round to check your reactions to all 3 drugs. The first day I was there about 8 hours and had Rituxan which I have had over 20 times before with little or no reaction. I also got a drug to prevent pneumonia and this was given thru an inhaler. This time my reaction was a little different. I developed a slight fever before I left the infusion center, but nothing major. When we go back to our hotel I started feeling worse, with flu like symptoms, chills, and my fever went up to 100.5. I was concerned that I was going to get worse, but I knew this was a common reaction to Rituxan, but one that I had not experienced. I took 2 Tylenol and 2 hours later I felt fine.

This morning I had a full breakfast and went in for my next infusion, this time a drug called Bendamustine or Treanda. They drew my blood first and my WBC went from 53K too 28K in one day, which is pretty much expected from Rituxan. It was a quick infusion (45 min), but because of the trial they have to do a blood draw on a continuous schedule for the next 6 hours. We did have 2 hours between the last two tests, so we got to get out and go the mall. We even got to go out to dinner with Lisette and Angelo, which is always fun. So far I have had no real reations to this drug. I am hoping it will last.

Tomorrow I go for a second dose of Bendamustine and the first dose of the Clinical Trial drug. I am hoping the non reactions continue, but it will be a long day, 8 hours of blood draws. the next two days I only get the trial drug and am not sure how long they will keep me.

Thanks for all the emails, facebook posts and prayers. I definitely helps me get thru all of this.
Terry

05/05/10 – At the Starting Line

Using an analogy that 'the lights are yellow and we are waiting for the Christmas Tree to turn to green' (that's for you Jack). Does anyone else get this? I have passed all the medical and administrative hurdles and am scheduled to begin the treatment on Tuesday, May 11^th. It looks like I will be down there for 5 nights for the first month of treatment. They proceed very slowly to watch all of your blood levels and reactions for the first doses.

Other than the fact that I have been diagnosed with shingles, I am doing fine. I don't have any of the redness or blisters but just have the stabbing pain. After two visits to Prompt Care and two incorrect diagnoses, I finally got confirmation on Tuesday when I went to La Jolla. I apparently don't have any of the classic symptoms because I am on an anti-viral, and that probably stopped the outbreak. It was interesting to hear their comment at La Jolla ' oh yeah, we see that all the time' to the comments at Prompt Care 'hmm, never seen that before, must be a pulled muscle, it can't be shingles because you have no rash'. I did have to increase the dosage of the anti-viral to help get rid of it. I was afraid they were going to postpone my Trial again, but they said with no outbreak, I am good to go.

I have talked to a couple of people that have been on the Trial drug by itself and there are minimal side effects. A few GI problems and some fatigue, but that goes away in a couple of days. Since we are adding two additional drugs to the trial, I also have to be aware of any side effects from those as well. One of the two, Rituxan, I have already had many times, with no problems at all. The last drug, Bendamustine is given in a smaller dose than it would have been if I was just getting it alone, or in combination with another drug, so I expect there to be few problems with that as well.

The Trial will last 6-8 months depending on how I respond and if there are any drops in blood levels that would cause a concern. There is a woman at UCSD that is on this same protocol and after 4 cycles she is responding quite well. So we can hope for the same response from me.

I will keep everyone updated more frequently next week during the trial.

Terry

 

04/27/10 – Let’s Try One More Time

I know you all were left hanging at the end of my last post, so now we have a new plan. I will begin the Clinical Trial on May the 11^th. End of Short Report.

I did have the lung biopsy on April 19^th and we were waiting for the results so we could figure out what to do. On Friday (the 23^rd) they called me and told me that the preliminary evaluation showed no lung cancer or identifiable infections. They also said that they could not determine what it was, and they would continue looking at the biopsy and the films. Today they called me and said that after they cultured the biopsy there were no infections found, and they have determined that it is scar tissue from some previous infection of unknown origin. This is good news because they don't have to do anything to get me ready for the Clinical Trial.

Because of the nature of this study, there was a fear on my part that I would have to redo all the tests that I have done in the past month (EKG, Echo, and CT Scan). Also of concern was the fact that my last bone marrow biopsy was done in January and I was afraid they were going to have to do that test again. But apparently the Clinical Trial coordinator from UCSD called Abbott and cleared me to NOT have any more tests except for one more physical exam and round of blood tests. That appointment will happen on May 4^th, and I will begin the Clinical Trial on May 11^th. The first round is for 8 consecutive days with drugs being given the first 5 and tests given the last 3. The second round is 28 days later and is only for 3 days. They monitor you pretty closely during this trial and I will have blood tests every week. This cycle continues for 5-7 months depending on how I respond. As of right now there are only 4 people in the entire U.S. that are on this particular trial so the results will be of great interest to everyone.

So now I am just waiting for all the confirmations on my appointment schedule and we will begin.

Let the show begin.

Terry

04/08/10 – The NEW Plan

If you remember from my last post, I was waiting to find out what is going to happen next. Well, I found out, and here is the new plan. They are still concerned about the 'shadow' on my lung. If I wasn't going into the clinical trial they might have ignored it, but because they have very strict entry requirements they want to make sure that I don't have anything else wrong that could skew the results of the trial.

So next Wednesday I go down to La Jolla for the 'consult' about the procedure. Then the next week on the 19^th I go down for the actual procedure. Now why in the world I can't do both on the same day is beyond me, but that is the plan. I guess because of the type of procedure they need to give you time to 'back out' if you want to. I told them I don't want to 'back out', but it didn't matter. So then we wait until all the experts figure out what is going on. Right now it could be one of about 5 things. A previous scarring from some past illness, a precursor to pneumonia (the one that Donna had, but I didn't get), a nodule of leukemic cells, a fungal infection, or something more serious. Right now they are 95% sure it is one of the first 4. If it is something simple I may begin the treatment in May, but if it is something else, then it may take a while to clear up.

What is hardest about this whole thing is the waiting and the uncertainty of it all. I already have enough of that going on and now this on top of it. I was very excited to begin this trial (and still am if it is to happen).

Terry

04/03/10- Poked, Prodded, Viewed, and now Waiting

April 1st, (no fooling), I went down to UCSD to get my Clinical Trial evaluation done. It was no big deal other than the 8 hours of being there (with 5 hours of that just waiting around. Hopefully I checked out OK because this is the last step before I am accepted for the trial. I had blood drawn (14 vials), a physical exam, an EKG, and echocardiogram, and a CT scan. All of this they pass on to the trial folks (at Abbott), who give their thumbs up or down (kind of like the Roman Gladiators). I didn't expect to get any answers so soon, but Dr. Kipps called at 4:30 on Friday and told me that they saw a 'shadow' on my lung in the CT scan. Right now they don't know what it is. It could be a pocket of leukemic cells (good), or a fungal infection, or something else. On Monday he will get the team of radiologists, pulmonary guys together and try to see what is going on. The possibilities are a lung biopsy, or a bronchoscopy, or a PET scan to get more definition. In any case, it looks like I will be going back to La Jolla next week to figure this out. It also means that I probably won't be able to start the Clinical Trial on April 13^th, unless they can clear up this thing up quickly. They have to get this out of the way before I begin treatment because they don't want to be treating two things at the same time.

Also yesterday we found out that Donna has 'walking pneumonia' and was put on antibiotics yesterday. Of course last night I started feeling bad, so I started my Z-pak to try to ward off anything that might come my way.

It is always something…

Terry

03/24/10 – The Human Guinea Pig

It has been a while since I have posted but after my visit yesterday I finally have something to write about. Since I finished my treatment in November my platelets and hemoglobin have remained stable, my white count however, is slowly increasing. What this means is that the AIHA is under control but the CLL is starting to raise up its head again. After my visit with Dr. Kipps yesterday he indicated that a couple of my lymph nodes have gotten slightly bigger, but my spleen has remained down in size. None of this is cause for immediate concern, but does point to the fact that we probably should consider doing something. He would like to see me in good physical shape whenever I begin treatment. Considering how fast this can move it is probably a good decision to start looking at something now. After a lot of analysis (does that surprise anyone?) we have decided to start treatment this time with a Clinical Trial. We started the initial consultation yesterday and will probably get more definite dates by the end of this week. The treatment will require 8 days down in La Jolla the first month and then 3 days a month for the next 5-7 months. End of Short Report.

There were actually 5 different options that we discussed and for a variety of reasons the ABT-263 Trial seemed like the best one for me. A lot has to do with where your counts are, what your past issues have been (AIHA for me) and what your genetic markers are. The clinical trial that I am looking at is one that combines ABT-263 (the test drug) with Bendamustine and Rituxan. Dr. Kipps just came back from a conference of CLL gurus where he gave a presentation on the effectiveness of this drug in the trials they have done so far. Back in July I posted information about the ABT-263 trial in a single agent mode. This new trial uses ABT-263 with a combination of known CLL fighting drugs. The following paragraph details how this drug is supposed to work.

Bcl-2 Family Protein Antagonists (ABT-263) Apoptosis, also known as programmed cell death, is a natural process by which damaged or unwanted cells, including those that are or could become cancerous, die and are cleared from the body. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, in tumor formation, tumor growth and resistance to treatment. ABT-263 restores programmed cell death by blocking the function of pro-survival Bcl-2 family proteins. Pre-clinical data have shown that Abbott's Bcl-2 family protein antagonists effectively kill certain cancer cell types.

I have to go down to La Jolla once before the trial begins to go thru all the screening process (blood tests, cat scan, EKG, echocardiogram, etc) If I pass all of that, then on to the Trial. Based on firsthand knowledge from friends that have undergone clinical trial treatments, they often come with side effects (think the Pepto Bismol commercial), unwanted changes in blood counts, and sometimes just don't work. Based on the trials that have been done with ABT-263 alone the side effects have been mild but there are several things that must be monitored such as liver enzymes and platelet count. As with any clinical trial they want you monitored closely and that is why I will be down there for 8 straight days the first month. After those 8 days I go down weekly to be checked to make sure I am not having any major problems. The next 2 months I go down for 3 days of drugs and then back weekly to be checked. For the next 3-5 months I will go down monthly for 3 days. They are not sure how many cycles that I will be receiving because it all depends on how well you are responding and if there are any side effects. On the plus side the drug company (Abbott) will reimburse me for lodging and travel expenses for the times I have to go down there. I just got my confirmation today and will go to my screening on April 1st, and assuming I pass, will begin my treatment on April 13th.

I am not really happy about doing this trial; I wish I didn't have to do it at all. But I guess it is better than the alternative. I am happy that we are starting to make a definite plan for treatment because I was getting tired of this 'waiting game'. On the plus side, I am feeling really great. Have taken a couple of trips in the last several months and am playing golf on a regular basis. As usual, I rely on Faith, Family and Friends to make this journey easier for me.

All the best,

Terry