Years ago, I developed a friendship with a guy who was intrigued by me. Granted, we were mutually smitten, but he had a high level of curiousity about me and my life--he inspected details of my living quarters and activities, asked probing questions, and analyzed the available data. One evening, over wine at the bar of a fine dining establishment, his questions and assessments of me led me to exclaim rather loudly, much to the amusement of the bartender and other patrons, "I am NOT your little science project!" For better or worse, the escapade fizzled before much more probing or anything that might have resembled a normal relationship.
Now, again, I find myself as someone's science project, again having myself questioned, probed and evaluated, but in a a much more formal situation. I have entered clinical trial-land. I am not just a patient, but a subject. BFF D suggested that perhaps I am now a "trial" lawyer. Hmmmm . . . .
This trial (unlike a flight of fancy that might lead to a bit of joyfulness) could lead to a significant advance in the treatment of breast cancer--not just for me, but for many other women. This is far more important than my own personal happiness--it is a matter of public health with far reaching ramifications. I am excited and delighted to be a part of it (even though it does not come with free drinks or backrubs.) It is one step in my path of lifelong cancer treatment. It is not intended to get rid of the 20ish % of cancer that still remains in my body (although some regression is possible). It is intended and hoped that it will slow progression of my cancer and make future treatments more effective. This could be a beautifukl thing.
The trial, being conducted at Johns Hopkins Sidney Kimmel Comprehensive Center (JH) is of a breast cancer vaccine, specifically, "Cyclophosphamide and Vaccine Therapy With or Without Trastuzumab in Treating Patients With Metastatic Breast Cancer." Got that, right? The trial is still open and looking to enroll more patients. Basic criteria: Must have metastatic HER2 negative breast cancer. Must not have autoimmmune disease. Must not have chemotherapy within 28 days of the study. Patients wanted!! In all seriousness, if you might be eligible, or know someone else who might be, call JH or contact me and I'll make the connection.
So here's the deal, in basic non-scientific terms. This is a research study, meaning the vaccine has not yet been approved by FDA, and is only available to a limited number of patients--me and 39 others, thus far, in a very highly selective eligibility process (e.g., if the selection were based on academic criteria, I likely would never get in!) Studies like this can provide the basis for a new treatment to eventually be approved by FDA and become widely available if the data are sufficiently robust.
The vaccine (aka immunotherapy) is intended to arouse my immune system and feed it with information along the lines of "breast cancer cells are bad. Destroy them. Breast cancer cells are bad,. Destroy them. Repeat after me--breast cancer cells are bad . . ." See, our immune systems don't consistently recognize cancer cells as bad, because they grow from within our own bodies, and are not viewed as foreign. (wow, this almost sounds politically incorrect . . foreign=bad.). The vaccine, manufactured at JH, is composed of breast cancer cells from other patients (thank you, other patients whoever you may be, and I know there are no cells from Henrietta Lacks, because I asked.) and a protein called Granulocyte-macrophage colony-stimulating factor (GM-CSF). The trial has two arms: arm one is testing the vaccine along with cyclophosphamide (a chemo drug, aka, cytoxan, that I was provided back in 2010, old hat to me . . ); arm two is testing the vaccine along with cytoxan and trastumzmab (herceptin, which I had not had the pleasure of until this week). These two drugs are administered at low doses prior to the vasccine, to assist in priming the immune system. I am in arm two. GO arm two; beat those arm one wimps!! (Only kidding. In the name of science, may the best treatment regimen win,)
This is part of a new wave of cancer research. Unlike chemotherapy that destroys and knocks you down, immunotherapy boosts you up--gives you (me) the patient, the tools to fight off cancer growth. It is cutting edge. Forward-thinking. Trendy. Despite my personal trendiness, being accepted into the trial was not at all a sure thing. This aspect is actually very interesting, because sponsors of clinical trials are very often seeking to enroll patients, and yet--it can be difficult to be accepted . . a challenge to find exactly the right fit. Sort of like dating, I suppose. After three visits to Hopkins involving talking, responding to questions, being examined, and having numerous tests of the type one cannot study or cram for (CT-scan, bone scan, echo cardiogram), I was officially accepted into the trial. The acceptance conversation was rather mellow.
Dr. E, the Principal Invesigtaor (EPI): I think you're eligible.
CD: Eligible, or in??
EPI: Yes, you're in.
CD, with big smile: Yay!! (I restrained myself from doing a little victory dance right then and there . . )
I reported in to Dr, S the next day. Dr. S had mentioned this trial to me many months ago. It is very high on his list of options, and it was similarly lauded by others I am privileged to know as well.
Dr. S: Well?
CD: Did you hear? I'm in!
Dr. S: Oh? (seeming a bit surprised, having been disappointed before, or perhaps because he had not read about it on the front page of the Post.) Good!
CD: Oh, ye of little faith . . . I do get what I want, you know. well, maybe not with this cancer thing, but in lots of other ways, I do . . . I will not disappoint you, Dr. S, I promise . .
How could they not accept me? Seriously. I'm vigorously healthy (other than that cancer thing.) I have some detectable cancer (a necessity for the trial), but not too much . . . (disease that is progressing too fast, not stable, could result in ineligibility). I am stage IV (a necessitty for the trial), but very early stage IV (perhaps a better gamble?). I am HER2 negative (a trial requirement). I do not have autoimmune disease (importsnt because of the necessity that one's immune systems react to the vaccine.) I am trendy, in line with the cutting edge nature of the vaccine. I am very good at following directions (perhaps inclined to break rules in real life, but not here, where I really really don't want to be kicked out). I am willing to travel to JH in Baltimore for many many days in a row for the next several months. I liked and commented on EPI's bright blue and orange hand and toenail polish colors and am willing to compete in a nail-off as the trial continues. :)
So, I'm in. I started on Monday. I have an Orange JH patient card that I scan upon entering the facility, so they know I'm there. I have coupons for free parking (a clinical trial deal.) Beautiful Older Sister (BOS) flew up from Florida to accompany me, every day this week. Details on what I do there every day to follow in a later post (yes, colleague K, I know my posts are lengthy.)
This is new territory. For science and for me. I am feeling brave and lucky and primed for the future.