Mets Day 85 - clinical trial update

This afternoon I heard from Fox Chase, who told me that I had been tentatively accepted into the Dendreon clinical trial.  It's a double-blind Stage 2 first-in-human test of an immunotherapy drug named DN24-02 as an adjuvant therapy in patients with high risk HER2+ urothelial carcinoma (e.g., me).  For those of you who are wondering, DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein.  Got that?   Half the patients will get the drug, and the other half will just be followed with a series of scans.  According to Dendreon, the purpose of this study is to compare the length of survival between these 2 groups of subjects. Other purposes of the study are to learn about the safety of DN24-02, to learn if it delays the time until urothelial cancer recurs, and to learn if the immune system responds to treatment with DN24-02. All subjects will be followed for this study for the remainder of their lives.  More info about the study is available here.

Dendreon has developed and sells a prostate cancer drug named Provenge.  It's not releasing a lot of information about this new drug, however.  The treatment portion of the clinical trial will consist of my having blood taken, sent to Seattle for infusing with the DN24-02, then sent back to be infused back into me three days later.  This will happen three times, with two weeks between each infusion.  Then Dendreon follow me with a series of scans until I die.  After I complete this trial, I am free to do other trials, or seek other treatment.This is about the only clinical trial for someone in a position as me - no distant solid tumors yet, but at high risk for developing them.   

I'm tentatively scheduled to have a series of scans at Fox Chase on Thursday, July 12 -- a CT scan with contrast of the chest, abdomen and pelvis, plus a MUGA scan to check cardiac function.  I was going to have the same CT scans on July 9, but I've cancelled those.  I will proceed with the bone scan on July 9, however. 

I realize this clinical trial is merely an experiment, and I'm a lab rat.  I have little expectation that this clinical trial will do any good.  Even if it does, I probably will never know, since it's a five year study, and the object of the clinical trial is to see who lives longer -- those who got the drug, or those who didn't.  But it's the only option right now, and the doctors at Chicago, Hopkins, GW and NIH all thought it was the best choice for me. 

Meanwhile, I am still having trouble peeing.  When I try to go, little comes out.  When I am not trying to go, sometimes I involuntarily start to pee.  I run to the bathroom, and . . . nothing.  Maybe, just maybe, the Cipro is starting to make a difference:  last night, before I went to went to bed, I sat on the toilet for about 15 minutes and worked really hard to drain my neobladder (squirt . . . wait 15 second or so . . .  squirt . .  wait 20 seconds or so . . . you get the idea).  For the prior week or 10 days, I have not even been able to have those series of squirts.  Getting up in the middle of the night to try to pee some more did not accomplish much, however.  But perhaps as a result of my trying extra hard to drain my bladder before bedtime, my Depends was somewhat less sodden in the morning.  I'll take those little victories whenever I can get them.

[edited July 12 to correct information about the clinical trial]