SO, you want to be in a Clinical Trial (prt Two)

So here we go with some medical jargon. Please try and keep up. It’s important and fascinating stuff. I must warn you, though, it is complicated. But bear with me. 

The clinical trial that I have enrolled in involves a vaccine, called TPIV200, and is based on a theory that your immune system is the key in fighting cancer. Much like when you have a cold, it is your immune system – and the health and strength of your immune system – that fights off your cold and rids your body of the symptoms and germs of a cold

Ok, so a bit about your immune system. According to Dictionary.com, “your immune system consists of lymphocytes – or T cells - developed in the thymus, that circulate in the blood and lymph system and orchestrate the immune system's response to infected or malignant cells, either by lymphokine secretions or by direct contact. “Helper T cells” recognize foreign antigen on the surfaces of other cells, then they stimulate B cells to produce antibody and signal “killer T cells” to destroy the antigen-displaying cells. Subsequently “suppressor T cells” return the immune system to normal by inactivating the B cells and killer T cells.” Wow!. Did you have any idea all this was going on inside your body when your nose begins to run, and you feel like crap?

Still with me? Alright. Now we go even deeper into the molecular level. Hang tight. From Cancer.gov: “Folate Receptor alpha (FRa) is a protein and a member of the folate receptor family; this receptor is overexpressed in a majority of ovarian cancers and in about 50% of breast cancers – including Triple Negative Breast Cancer - and is associated with cancer recurrence”. 

Oky doky. Now that we have some background from which this vaccine was formed.....From the company who developed the vaccine: “TPIV200 is a multi-epitope, peptide-based cancer vaccine that has been shown to induce a robust and long-lasting “memory” T-cell immune response directed against folate receptor alpha (FRa), a molecule that is overexpressed on the surface of the vast majority of TNBC cancer cells and is associated with cancer recurrence. TPIV200 is uniquely able to stimulate both “helper” T cells and “killer” T cells to target tumor cells…”

I truly believe this is the future of cancer treatments. Stimulating your own immune system to hunt down, target, and kill cancer cells. I’m excited to be a participant in this trial. As with any clinical trial, no one knows if this vaccine will work. The trial is set up to test a theory. A strong theory, but just a theory none the less.

I am involved in the second stage of this trial, which began recruiting participants in early 2018. Phase One of the study – which completed in 2017 and published results in early 2018 - showed that 90% of the participants developed a “robust and durable” immune response against FRa, and that the vaccine was well-tolerated”. Pretty good so far...now, to see if it works!

Phase two of the trial is looking to enlist 280 participants and is sponsored by Mayo Clinic. Keith L. Knutson. Ph.D., Professor of Immunology in the Department of Immunology, and Edith A. Perez, M.D., Professor of Medicine in the Division of Hematology and Oncology, both at Mayo Clinic’s Florida campus in Jacksonville, Florida. The University of Miami's Sylvester Cancer Center, where I receive treatment, is one of several satellite locations around the country for the trial.

The Mayo Clinic received $13.3 million in grant funding from the U.S. Department of Defense (DoD). Yep, that’s right, the Department of Defense.  Strange funder, you say? Well, perhaps not.  According to the National Breast Cancer Coalition, “the Department of Defense Breast Cancer Research Program (DOD BCRP) was created in 1992 as a result of the National Breast Cancer Coalition’s “$300 Million More” campaign to increase federal funding for breast cancer research. Due to the efforts of the National Breast Cancer Coalition and the leadership of Senators Tom Harkin (D-IA) and Alfonse D’Amato (R-NY) in FY1993 Congress appropriated $210 million in the DOD research and development budget for a breast cancer peer reviewed research program administered by the Department of the Army.

DOD BCRP’s unique grant structure allows it to fund innovative, high-risk, high-return research and quickly respond to current scientific advances. In addition, the DOD BCRP can fill gaps by focusing on areas of research that are promising but otherwise underfunded. 90% of the appropriated funding goes directly to competitive, peer-reviewed research grants awarded to the best science. And it has produced extraordinary results. From new methods of extracting breast cancer cells at their earliest stages, to unprecedented research into gene/environment interaction, to quality of life issues, the DOD BCRP leads the way in generating new approaches to breast cancer prevention and treatment. It has produced fascinating insights into the biology of breast cancer and has directly impacted lives through the research it has funded, such as the revolutionary work that led to the development of the innovative drug Herceptin.”

Ironically, I was a young staff in Senator Harkin’s office in 1992. Karma has a fascinating way about it, doesn’t it? -------------

SO, you want to be in a Clinical Trial? (prt One)

I stepped into the shiny new train and eased into one of the comfy seats with lots of electrical plugs handy. I tried not to think too much about what was about to happen, because doing so brought tears. Not fearful tears, but tears of hope and tears of sadness. I was bound for Miami - 30 minutes by train - to begin a clinical trial to hopefully save my life and the lives of others diagnosed with Triple Negative Breast Cancer (TNBC).

Just the day before, ironically, I “celebrated” my 365th day cancer free. A birthday of sorts. Some women begin counting on the day of their diagnosis. Under the reasoning that we all become survivors the day we take on this fight. Others, like myself, prefer a more joyous date to memorialize - the date I was finally free of cancer. That date for me is July 24. The date of my double mastectomy. My surgeon found “residue cancer” within my tumor during surgery and removed it along with my boobs in one 4-hour operation. As a cancer patient, you hope for pCR (Pathological Complete Response) meaning there is no cancer left after chemo therapy. Approximately one-third of TNBC survivors receive pCR. I, however, was not among them. 

From the very moment of my diagnosis, I knew I wanted to be a part of finding a “cure”.  If this fucking disease was going to enter my body, I was going to fight like hell to kill it - for me and for anyone who would have the misfortune to follow me.

Finding a “cure” for cancer - all cancers - lies in the field of clinical trials. Basically, doctors and researchers think they may have discovered something, a drug, a test, a vaccine, but to find out if it helps or works they need humans to step up and offer their bodies to research. Many folks find themselves on clinical trials because nothing else it is working for them. They have metastatic cancer (stage IV) which at that point is incurable. They’ve tried all proven methods, drug, therapies, yet they continue to get sicker.  I, fortunately, am not in that position. I’m entering a clinical trial to hopefully keep my cancer from returning. Thus, helping others remain cancer free, and in doing so I’m willing to take on the risks of the unknown. Look, once you have stared down cancer, little else is as scary.

The train rolls into the bright and shiny new Miami station. This high-speed train has only been making this trip for a couple of months. I step out and make my way to the Sylvester Cancer Center, located at the University of Miami, where my clinical nurses are waiting for me.

To qualify for this clinical trial, or any clinical trial, you must pass a rigorous and extensive list of prerequisites. For this one, I qualified on my diagnosis of TNBC, having residue disease post chemo, and having ended all treatment within 365 days. I qualified on that last one because my treatment included an additional 18 weeks of “extra credit” chemo (Xeloda) because of having residue cancer. For me, my treatment ended December 31, 2017.

I also had to have blood and urine tests and somehow pass those, which I did. AND I also had to “prove” my cancer had not yet returned - or in the process, find out it had. To do this, I needed to have CT scans of my chest, abdomen, pelvis areas and a bone scan. Well, if you have been following along, you know by now of the “scan-iexty” that comes from having to chase down every little blip on a screen to prove it’s not cancer (or find out it is cancer), but instead a cyst, or other benign thing that everyone has, but you don’t know it, can’t feel it.  Three months of all that and I eventually passed that big and scary hurdle as well. Phew!

I am met in the lobby of the Center by no less than five clinical nurses, research assistants and various interns. They, along with my breast oncologist, will make up my team for the duration of the trial (more on that later). Together, we move as a pack down the narrow hallways, up an elevator, across the buildings, down an elevator to the CTU, the Clinical Trial Unit. -------------