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.