Day One of CAL-101

It's the middle of a long day in the treatment room as I type this. John has begun to refer to himself as a guinea pig because this is the second time he is participating in a clinical study. A lot of people hear "clinical trial" and ask me if John will know whether he's getting the "real" drug or something else. This is not a blind study. There is no control group getting a placebo. In fact, I don't know if they even do those types of studies when it comes to an incurable cancer. I kind of doubt it, but I'm not aware of any for CLL. All of the studies I have researched compare different treatments or study different combinations of drugs for effectiveness, dosage levels and degrees of toxicity.

When John did the last study, he was getting the "gold standard treatment" for CLL (Fludarabine, Cyclophosphamide and Rituxan), PLUS an experimental drug (a monoclonal antibody called Lumiliximab). FCR works the best for the most patients. That's why it is considered the "gold standard." The purpose of the study was to determine if the additional drug (in combination with FCR) lengthened remissions. It did not and the study was closed right about the same time John was finishing his six cycles of treatment. But John was getting the proven treatment along with the experimental drug. He wasn't simply doing experimental treatment. However, as I've said before on my blog, he did not get a remission from six rounds of the "gold standard" chemotherapy. His lymph nodes started to come back right away. Very disappointing. And that's why we are in treatment again; this time with a new drug that is showing exciting results.

Prior to doing chemo this past fall, John tried Rituxan as single agent in the summer of 2008. We went with that treatment first because of the lower toxicity, not wanting to damage his immune system with the heavy chemo unless we had to. It worked great on his blood, but was not effective at controlling the lymph nodes. And the only reason he needed treatment was for his lymph nodes. John's blood has never been the problem. His CLL grows in his nodes (presenting more like a lymphoma, although it is technically leukemia).

For the understanding of someone reading who hasn't had to learn all this stuff, CLL is a malignancy of the b-cell lymphocytes, originating in the bone marrow. But it then infiltrates both the blood and lymph nodes. (Lymphoma, on the other hand, originates in the lymphatic system and then infiltrates the blood and marrow. Therefore, they are similar but different diseases.) CLL can progress in either the blood, the nodes, or both. The lymph nodes are harder to treat and often are more resistant to treatments that work well on patients whose CLL progresses mostly in their blood.

Some CLL patients are fortunate enough to stay in "watch and wait" for years before their CLL progresses to the point of requiring treatment. I wish John could have been one of those indolent cases. But he is not. He has a more aggressive form of CLL. This is the third treatment since his 2007 diagnosis. And he did not get good results from either of the first two. This time he is receiving only the experimental drug, CAL-101. There are other arms of the trial that combine CAL-101 with Rituxan or both Treanda and Rituxan. But we already know that Rituxan has not worked on John's nodes and we did not want to do more chemo this soon if there was a possibility of good results without it (because of toxicity). So far, CAL-101 is working well for many patients with no side effects and low toxicity. So we are hopeful John will get these same good results and wanted to try it alone.

John will take a pill twice a day (every twelve hours). The duration of this study is twelve 28-day cycles. So it will last just under twelve months. If John is getting good results, he should be able to continue in another phase of this trial (past the twelve cycles). Since there is no longterm data yet, nobody knows the longterm effectiveness or the longterm side effects. But it is continuing to work well for patients who have been receiving it for the last fifteen months. (That is the longest any patient of Dr. Flinn's has been taking it.)

Today they are taking blood from John frequently in order to determine when the drug peaks in his system. He has also had two EKGs. We have to repeat this "long day" of data collection again on the last day of the first cycle (June 24). But after that, John won't have any all day appointments. We will come weekly for the first two months so they can check his blood and give him another week's supply of pills. If he does fine for the first two months, then he should not have to come weekly for the rest of the study. I think his visits will be monthly from that point on.

Side effects seem to be low with this drug so far, but you never know when that one random patient is going to have an adverse reaction. And determining what those reactions can be are also a part of the study. So, here we sit for the rest of the day.

Truthfully, there is no place I would rather be. Unless something totally incapacitates me, John will never be here without his shadow (me).

It was this week, seven years ago, that I discovered John's profile on and sent him that first email. Within two weeks, we both knew we'd found someone really special. I plan on hanging onto this guy for a long, long time. And hopefully CAL-101will help me do that.