Start of the Clinical Trial

I have a lot of catching up to do, but if I try to do it all at once, I will never get going again on this blog. Suffice it to say that we have been busy. I am writing this as I sit getting more chemo. This time it is a prep drug for the lung cancer vaccine I will be receiving.

I have been declared "in remission" by my doctors. The idea of enrolling in a clinical trial is to continue to be proactive. Otherwise, the medical community really has nothing further to offer other than "monitoring", which I like to refer to as the "wack a mole" approach. Remember the carnival game where you hit the mole with a hammer as it pops up from various holes? That, in a nut shell, is the remaining strategy...if cancer shows up again, we'll "wack it" with more chemo or radiation. To say the least, such a strategy does not inspire confidence, because the same medical community will tell you that once the cancer spreads, it is only a matter of time.

I have elected to enroll in a clinical trial for a new maintenance drug (vaccine). The drug is called L-BLP25 Liposome, also known as Stimuvax. This is a Phase III (blind study) trial. Two thirds of the subjects will get the real deal and one third will get a placebo. After randomization, subjects in the investigational arm will receive, within 3 days of their treatment assignment, a single intravenous (I.V.) infusion of 300 mg/m2 (to a maximum of 600 mg) cyclophosphamide three days
before the first L-BLP25 vaccination. (This is what I had today.) This is followed by eight consecutive weekly subcutaneous vaccinations with L-BLP25 (primary treatment phase) followed by vaccinations with LBLP25 at 6-week intervals, commencing at week 13 (maintenance treatment phase). The study continues and we continue getting shots (one in each arm and two in the stomach) every six weeks until there are signs that the disease has progressed.

In previous studies, Stage IIIA patients who were stable and who received the placebo showed signs of progression of the cancer within 17 months; patients who received L-BLP25 showed signs of progression within 30 months. I am hoping to get the real deal, but we will not know.

Yoko and I had to drive up to New Port Richie (about 2 hours from here). We left the house at 8:15 this morning and arrived at the doctor's office at 10:30AM for our 11 AM appointment. They took blood, vital statisics and I had a physical. The chemo took and hour, but with waiting and all, we did not get out of there until 1:30. By then we were starving, so we ate and then drove home. As soon as we got home we had to get ready for Hurricane Fay...test the generator, move stuff in the house from outside, etc. We have buttoned down the hatches and are ready for whatever comes. It is a good analogy for our whole life these days.

More to come!