I did not get in to the lumiliximab trial after all. They have enrolled only one person at UC Davis. I developed a cold or upper respiratory infection and I was booted out of the trial.

However, my CLL has gone into overdrive, with a projected doubling time of only three months. Therefore, I was offered standard FCR or rituximab plus revlimid. I was really hoping for a second enrollment in the ISF 35/Memgen trial at UC San Diego under Dr. Castro, but there has been a long delay. It is just now enrolling.

(The thing they are most excited about are the 17p del CLL patients. The results so far have been promising, and the theory that a few cycles of Memgen followed by FCR might result in decent remissions for this hard-to-treat population.)

So I'm disappointed that I didn't get into a trial, but I'm more disappointed that I did not have the option of going on the ISF-35, multiple injection trial.

FCR+L Trial

A lot has happened since my last post. I've been trying to get into the FCR+L trial since May, and I finally am supposed to start on Sunday, September 22, 2008. (There is a wrinkle; I've just developed a cough, so I need to have that checked out before I start the trial).

I was notified on Thursday that I have been randomized to be in the arm of the trial that includes the lumiliximab. Lumiliximab is a CD-23 antibody. It works in a fashion like rituximab, but the CD-23 marker isn't as good of a target.

The difference is that the CD-20 marker is a transmembrane protein; it pokes part of itself outside of the lymphocyte, and keeps the 'tail end' inside of the cell, in the cytoplasm I would assume. The way these markers work is they are the 'eyes and ears' of the cell, sensory organs if you will. The marker detects a signal outside of the cell in the microenvironment, and then signals inside of the cell.

Being a transmembrane molecule, the CD-2o marker is a robust one, hanging on the the cell (in large numbers, in the thousands), resisting falling off and becoming useless. The CD-23 marker, unlike the CD-20, is much more easily dislodged from the cell, and a detectable fraction of the markers are found in the microenvironment. This makes the CD-23 marker less effective at killing CLL cells.

The hope the company who is pushing this MoAB through clinical trials is that it will enhance standard therapies. Small studies have suggested that this is true; the complete remission rate with FCR+L is higher than plain old FCR.

I am scheduled to start the study this coming week at the University of California, Davis Medical Center. Although I've gotten all of my treatment so far from UC San Diego, I opted for UCD this time because the trial protocol they offered me allowed either MRIs or CT scans. Anyone who knows me knows that I dislike CT scans because of the amount of radiation, which raises the risk of secondary malignancies, a complication CLL patients are already at higher risk for.

The secondary reason is that I live in Sacramento, and this will mean not having to fly down to San Diego for follow-up visits and all six cycles, assuming I would get that far.

As far as my general health goes, I am fading, but not at a fast clip. My biggest problem is my anemia. I am in the 8.8 range at last test, and this is not normal. Even the government will pay for Epogen if the hemo rate is below 10.0, which I am.

My other numbers are terrible, but sort of holding steady. WBC at the 200,000 range, platelets (always a problem for me) at about 75, and the red blood counts, as I've mentioned, a continuing problem.

My latest test should be on my fax machine when I get home tonight, so I should know if I need a transfusion in the next day or two.

My biggest problem right now is this cough I can't get rid of. Dr. Hamblin believes I should wait before I start the trial, and I am inclined to agree with him.

I think I got this latest infection (I've been remarkably infection-free even with terrible numbers, until this year, and I've had three infections since January) from using a neti pot. This is a device that allows you to pour salt water from one nostril into the other, draining stuff and supposedly keeping you clean. However, I made the mistake of just using tap water, which is not sterile. I usually boil the water, but just forgot.

This cough has now settled into my chest. Well will see what happens.

Still Waiting

I'm waiting for approval of my MRI imaging studies before I can enter the FCR+lumiliximab trial at UC Davis. The trial coordinator is Dr. Tuscano, who was nice enough to speak before the Sacramento CLL patient's group in 2006. He has been working on his own antibody, but I've not heard whether anything will come of it. It looks to be a less than rousing success, but the delays may be due to funding or other administrative problem.

So I'm in a holding pattern, in more ways than one.

One development is that I'm going down to UCSD to see either Dr. Kipps or Dr. Castro. We will see what is happening with my run-away CLL. I am less than happy with the skyrocketing counts that are not, so far, really apparent except in my large abdominal nodes. I don't feel any changes, still working full time and in the evenings seven days a week. Haven't been back in the mountains since I'm now anemic and I don't want to give myself a heart attack by hiking. Energy level has been dropping, but I'm sleeping fairly normally.

Lumiliximab is a CD23 antibody. CD23 is not expected to be a slam-bang MoAB like rituximab for the simple reason it doesn't seem to has as much killing power.

The most recent study and the reason I think Dr. Kipps has recommended this study to me is that the complete remission rate is almost 50% in previously treated patients, which is a very good result. Overall response rate is 95%.

There are two arms to the study, and you don't know what you are getting into before you sign up. You do know once the treatment is underway, so I will get at least one FCR course if I am accepted into the trial. I have more negatives (low platelets, etc.) than I did before trial number one and two. The more things wrong you have with you, the less likely they will choose you to be in their sample. They do want a success, and some folks have been accused of 'cherry-picking' patients that they think will do well for a particular trial.

It's such a game; a game with deadly consequences for the patient, at least.

I saw an oncologist at UC Davis regarding the FCR+Lumiliximab trial (a word she cannot pronounce accurately). This is the same trial which was offered (recommended?) to me by Dr. Kipps. However, Dr. Hamblin calls this trial just a 'marketing scheme,' a phrase that I don't understand. I'll have to write him and ask him to explain.

I don't want to use fludarabine, of course, since it is linked to significant T cell suppression, secondary malignancies, premature death and a whole host of other problems. Once you are refractory to fludarabine (and you will become refractory), then they are no real options left for you; make sure your affairs are in order!

I was more interested in the lumiliximab trial (which is a randomized phase II trial, somewhat rare) as offered by UCD over that of UCSD, since the trial at UCD offers the option of MRIs instead of CT scans. Funny that the same company would have different protocols for different institutions. I did e-mail the company complaining that MRIs would be just as effective as CT scans at tracking the disease. The company MD who replied to me said it would be up to the trial administrator. However, the written protocol is different for the two institutions.

I'll keep this blog posted as to what happens.

CLL Rampaging Out of Control!

Since my last post, all hell has broken loose, and my CLL is out of control.

My last blood test on June 19 had my WBC declining by 20k or so. I expected at least only a modest rise, if any, based on how I felt.

Wrong!

My numbers have gone sky-high, from about 30k to over 176k, in one month. I guess this qualifies as doubling in less than six months.

Thank goodness for blood tests, because I wouldn't have known I was going downhill so fast without them.

We've decided to treat as soon as possible, with something. We've decided that I should get a blood retest this week. I've been putting it off because, well, ignorance is bliss??? Isn't it???

With all the new knowledge and the prospects of better treatments in the next few years, why is this going so quickly downhill for me? That's just the way it is.

If CLL has taught me anything, it has taught me that we are all dying, some of us have it thrust in our faces every day, others only know it as an abstract thing. I used to confront this like the rest of the world, as a distant possibility; not now.

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We don't know if it's Richter's transformation, rapidly progressing CLL, a new cancer, or something else.

My only 'B' symptoms is that I'm tiring a bit earlier than I was a few weeks/months ago.

I'm not buying extra supplies that I might need 'someday'. That's a waste of money.

Vacation from CLL

I last saw Dr. Kipps on June 19, 2008. I cancelled the July 3 appointment with Dr. Castro because it relates to the ISG-35 internode injection trial which I failed in late May. (I went from 30k to 60k in three weeks. Bummer.)

I've had several major issues with my wife. She has asthma and the hot and smoky weather in Sacramento (we always have very hot Julys, but not smoky ones) has affected her in a major way. I've shifted my focus from my CLL to her asthma.

So, the last week, I've been feeling so good I decided to cancel the July 24 appointment with Dr. Castro (also on the failed clinical trial. I thought blood work here in Sacramento would give them a picture of what is going on with me, without having to fly down to San Diego, and spending the full day down there. I hate that!

I decided I would take a slight vacation from my CLL, in a way. I thought I would take the last week and one-half, and just not think about my CLL or any other medical problems.

I got a blood draw on Monday. I'm hoping the WBC is still low, and all of the other numbers continue to be stable.

I went for a hike on Sunday and did extremely well, felt fine, and thought about doing a long hike in September or so, if I can get in appropriate condition. I was worried about anemia as I had a night of blood pounding in my ear (see Dave's blog; he found it was associated with autoimmune hemolytic anemia), but I did fine and felt wonderful. I don't think I have significant anemia, if I have any at all.

It is nice to not have to think about CLL for a week and a half.

Takin' a break

I'm obviously informal since I am using an apostrophe instead of a 'g' in taking!

The weather has vastly improved. Last week was what Sacramento is famous for, hot weather! And it was hot, hot, hot! We topped out at 109 or 110, depending on where in the Sacramento region you are.

I bought a window air conditioner for the laundry room, for our semi-feral cat Mrs. Chippy. It was so terribly hot in the garage (the laundry room is the breezeway, sort of, between the garage and the house. It worked great! For $62, it was a bargain and it lowered the temperature into the 80s, a big relief from the 110 degrees it was probably in the garage. I'm going to keep the A/C there until summer is over in two months, and then put it away until next year.

On the topic: I've decided to take a break from CLL. I know that sounds odd, but I've had treatment in September, October and November 2006, and then again in May, '08. I had a partial remission from the HDMP+HDR (high dose rituximab), but relapsed quickly. I have terrible markers and no one, including me, was expecting me to last 10 years with this form of CLL. (It will be 10 years on October 1.)

My last blood numbers on June 19 showed a nice drop from my rapidly escalating WBC, and I feel pretty good, so, why not? I did see the local oncologist at UC Davis regarding the lumiliximab (randomized to 1/2 of the participants) trial. They remarked that they thought it was odd I'd be undergoing treatment when my performance level is '0' (zero, the lower number the better), working full-time, etc. So I took that as sort of a sign, maybe from God, to ignore the disease for a month. I'll have my next blood test on July 19, which is coming up fast. We will decide what to do then.

In the meantime, I am chugging away. My wife, who has severe asthma, is having trouble with our high temperatures and smoky conditions. Visibilities have been on the order of a mile or so. Terrible. You can see the smoke in the air, the sun 'sets' about 4 pm, and there is actually ash falling nearby. It has been a horrible year.

Note the sad loss of P.C., Chaya's husband, Tony Snow and others from cancer. This disease seems to take the best and the brightest, doesn't it? I don't have survivor's guilt, because I will most likely die from CLL unless something else gets me first, and it could happen in a hour, a day, or a week from now.

So, a short break from researching CLL, reading CLL blogs, thinking about the physiological nature of the disease, etc., is in order for me, and, I might add, richly deserved, at least in my opinion!