The latest

Saw Dr. Kipps on Tuesdays, the only day he pretty much sees patients. I had some CLL friends in San Diego who were very nice and ferried me around a bit, picked me up from the Cancer Center and helped me get around. Also, they took me out to dinner at a place called Milton's. It's a Jewish-style restaurant in La Jolla. It was very good; the pastrami was excellent. I had a soda called Dr. Jones (I think) and it's apparently a NY classic that you just can't get many places. It was good and made me feel a bit of a connection to NY, which I've been to exactly one time (to see an herbalist who cured one man of CLL, though no one else, to my knowledge).

Dr. Kipps is worried about me, since my counts are still in the tank. He suspects something else is going on. He wants me to start treatment again, giving me four different trial consent documents. Combined with re-doing flavopiridol or Cal-101 at Stanford, that makes six different protocols. That's if my beaten-up marrow has not transformed. He seemed pretty worried, and gave me a hug.

The bone marrow biopsy was pretty painful, even with the percocet I insist upon. (That was a problem in itself; Dr. Kipps apparently forgot to send the prescription over, so his nurse had to track down this busy man, and get him to write a script.)

So I am now waiting and worrying over what this latest biopsy will show. He said my last biopsy in May was fairly normal, and he doesn't understand why my counts are so terribly low (especially the white blood count) when the marrow looks OK.

There may be something else going on...

Life and Taxes

I am done with the flavopiridol/Alvocidib trial, and I have to get back to my life. I'm starting my federal taxes right now. In fact, posting here is a bit of a break from that very boring task.

I have long wondered why a few lucky souls who have deep, deep remissions of their CLL just drop out of the CLL society and 'move on'. It seems almost like a betrayal, doesn't it?

I will not be so lucky. My CLL has always been higher risk. When I was diagnosed, I exhibited the ZAP-70 marker, I was unmutated, and I had a 6q deletion, which is an intermediate risk marker. I was (and remain) male, and I was relatively young at diagnosis (48). All of those count as risk factors. So, from the start I knew I was not destined to be a smolderer. I envied all of those people (mostly female, it seemed) who could live with CLL and not have it be life-altering.

I delved deeply into the CLL on-line community, starting with the granddaddy (grandma?) of them all, the CLL list at acor.org, started by GrannyBarb. I learned a lot about CLL, and came to fear words such as 'refractory', and 'relapse'. I also learned that researchers are not one to pull punches; when I developed the 11q deletion, I read that folks such as me had a 'grim prognosis'. It's hard to let those words roll off one's back, isn't it?

Anyway, I am not going anywhere. At best, my flavopiridol trial gave me a partial remission. My terribly enlarged lymph nodes in my abdomen have shrunk, but not gone away. For 11q folks, published papers on flavopiridol show an average 9 month remission time. Then, apparently, the average person relapses. Based upon my previous history, my relapse may come sooner.

But at the present time, measured in weeks, I feel OK and feel as though I can devote a bit more time to work and family. Both have been pretty good, though one of my supervisors (she's since retired, thankfully) resented the fact that I was gone so much during my trial and demanded no let up in the work, which means that the three days a week I could work had to equate to five normal days. They did provide me with a converted small 'quiet' room that serves as my office. That was a great accommodation that allowed me to drag my room UV sterilizer in behind me and be somewhat isolated from the germs around the office.

In any case, I will be retiring this May. I really, really enjoy my job, but with that 'grim' prognosis hanging over my head, I can't justify working any longer. My retirement benefits to my wife would go way down if I die will still employed.

I used to have a co-worker who was diagnosed with colorectal cancer when he was in his early 50s, I think about 52. Kaiser did surgery, and he did well for a couple of years, and then the cancer came back. He retired when he started having lung mets. The doctor told him he had about three months left to live. It turned out he was gone in three weeks.

I want to have a retirement that lasts longer than my poor co-worker. So, it's adieu for all of my friends at work, and good riddance to the rest of them!

I hope I have more than three weeks.

Flavopiridol-Three Month Mark

On Thursday, November 12, 2009, I completed the third cycle of a planned six-cycle phase II clinical trial of Alvocidib (flavopiridol). Each cycle consists of four weeks of a one-day per week dosing, followed by a two-week 'holiday'.

As I've mentioned before, there is some thinking that as long as the drug is working, why stop it for two weeks every month? I concur with that thinking, especially if a continued pounding of CLL would conceivably result in a cure. However, flavopiridol has, per the latest published results of the trials (http://tinyurl.com/yhhp286) using the drug, only resulted in one complete remission. The over-all response rate was 53%, most of which were partial remissions. There was one complete remission in this study, which I've not read has occurred in previous studies.

And I must admit the two-week holiday is something to look forward to. It would be different if I lived in San Diego, but I don't.

My own experience is that I have responded to the drug. My main complaint prior to enrollment in the trial was large abdominal lymph nodes. I was doing my best to treat the lymph nodes with 3 mg per day of EGCG (the green tea component) and what ever else I could think of (curcumin, PEITC through watercress, vitamin D3, exercise, etc.) Eventually the lymph nodes elsewhere in my body, which had remained very quiescent, started growing.

My blood numbers have remained quite low since my sad experience with FCR, so low, in fact, that I worry I may never recover what passes for normal bone marrow function in a CLL patient.

My lymph nodes (especially abdominal) have been my greatest complaint.

After three cycles of flavopiridol, what have I learned? This is not a terribly easy drug to take, although I have learned how to mitigate many of the side effects. The first problem is the terribly ill feeling I get the evening after getting the drug. I feel very sick, very nauseated, often vomit, have persistent diarrhea, and just plain feel terrible. I have an elevated heart rate as well. It is all I can do just to get into bed and ride it out. Several times I have felt so unwell that I had to go to the emergency room.

To counter the nausea, I've insisted and insisted on adequate anti-nausea medication, which is surprisingly difficult to get. I guess everything that is given on a clinical trial has to be per the protocol, or you don't get it (exceptions of course are made; people don't die because life-savings drugs aren't on the protocol). I take ativan prior to the start of the flavopiridol, and get injectable zofran. This helps; I also have ativan and zofran to take if I feel nauseated later in the day.

The diarrhea is a problem, since I fly from San Diego back to Sacramento the day after getting the drug. After some experimentation, I use Immodium at the first sign of problems, and I take yogurt for the probiotics after I get back home. This (so far) had made the problem more mild.

The fatigue is something all CLL patients are used to; you just rest and do what you can do. It only lasts for the rest of the second day. By the third day, I'm back to the generally low-level of energy which accompanies CLL.

As I mentioned in the last post, I avoid the diarrhea-inducing medicine at all costs. Just thinking of it, or seeing the bottle, or remembering the taste makes me ill and wanting to vomit. Bleech! So I go on a low-potassium diet for three days before the treatment; this has kept my potassium level below the magic 4.0 so far. However, this is a very restrictive diet; I have created a chart of a variety of foods with their potassium levels. This means no fruits, nochocolate, no potatoes, no tomatoes, no soy, no milk, no bananas, no meats of any kind, no carrots, no raisins, no yogurt, no bran, no multi-grain breads, no nuts, no orange juice, no beans, and so on.

You are allowed white bread, white cakes, white cookies, rice krispy bars, water, oils of any kind, and small portions of cheese, iceberg lettuce, olives, pasta, and most soft drinks. But it is worth it to avoid the diarrhea-producing drug!

So, at this point, both Dr. Kipps and I are satisfied with the results. Flavopiridol can work on heavily-pretreated patients with unfavorable prognostic indicators, such as me. Thank God (and the researchers and the pharmaceutical industry)!. Otherwise, who knows where I'd be right now...

Barriers to Clinical Trials-the CT scan

I'm not going to write a book as I did on my last post!

Suffice it to say, some of the barriers to entry of clinical trials are listed on the last post.

I want discuss one real barrier to clinical trial entry that is easily remedied. That is the demand that participants undergo multiple CT scans to track progress (if any) in the trial.

Why is there a barrier? CT scans involve high levels of radiation, and they have definitely been linked to subsequent cancers.

The risk is low, the authorities say. But any increase in cancer risk sort of defeats the search for a cure for CLL, doesn't it? It certainly makes no sense when there is an excellent alternative: MRIs.

Clinical trials are done to look for results. The ultimate hope is a cure, because the drug in tests would be a huge success! Most likely, a more modest goal is envisioned: better results than current drugs.

Determining whether a drug is better than the standard treatment is surprisingly difficult. Drug companies can't wait around for 20 years to see if patients continue to do well (i.e. survive). Instead, they look for 'end points'. These generally include signs of tumor shrinkage or elimination. That is the reason drug companies want to check your nodes. The way most doctors are used to doing this is ordering a CT scan.

Yet we've seen the danger to the patient is real. Given a choice between a trial using an MRI and one demanding multiple CT scans, most people who are aware of the dangers of CT scans will pick the safer one, in other words, the one allowing the use of MRIs.

Why do drug companies deliberately rig their trials so people are less likely to sign up? It's a mystery, with perhaps a partial solution. Several of the drug companies I've talked to are aware of the concerns on the part of patients, and know that an MRI can track lymph node size just as well (or better) than CT scans.

Well, who then is the moving force behind this unfortunate situation? The drug companies blame the CLL researchers themselves! It is the research community that apparently doesn't care about patient safety to the point that they will allow safe alternatives to dangerous radiation exposure to patients.

I've discussed this with a few researchers in light of these claims. Rumor has it that there is a group of CLL researchers who are (pardon the expression) really anal about scans. The Germans.

I suppose we who are not German can recall the reputation the Germans have for meticulous record-keeping and administration. It apparently extends to CLL clinical trials.

Who ever is to blame, it's time the patient community help end the danger. Some of us need clinical trials if we are going to stay alive. We are sacrificing our bodies to advance science. It is incumbent upon researchers to watch out for our health. We are helping them (and the drug companies) when we sign up for a trial. They need to help us avoid doing more damage to our bodies than the investigational drug might cause.

Is your Health Care Practitioner Reading Your Blog?

A couple of years ago, I got a huge shock when I went in for some routine blood work in the big, fancy CLL center, and noticed my nurse was acting kind of funny. She mentioned something that I had posted on-line in one of the CLL lists. I had complained about something, and she was defensive about it. I realized that she, or someone else, had been reading my posts about my clinical trial!

For some dumb reason, I thought the only people who would read CLL group messages would be other patients. To be honest, I thought that oncologists and nurses were way too busy to even think about searching on the terms of a trial to see what patients in that trial were saying.

I've known for a long time that financial creeps troll the patient groups, looking for any information they can use to make financial decisions. Although less than honorable, I guess it's something that wouldn't surprise me too much.

But to have my health care practitioner looking for posts on a clinical trial floored me.

I am much more careful now. If I have anything at all even remotely critical to say, I say something like, 'a famous CLL doctor', or a nurse at one of the top CLL centers.' I'll use it every time I didn't want a particular doctor to read what I said about him.

After all, there is no reason at all to get your doctor or nurse mad at you.

The web is a huge party line. (Older folks are at least a bit familiar with the concept of the telephone party line. We used to have one. It was cool, but inconvenient at times.) Be careful what you say!!!