Two hours later, I was at NIH. I went to phlebotomy for the blood draw and urine scan, then went to radiology for the CT scan. The receptionist stated that she did now now not but have my orders from the doctor, so I went upstairs to the health center to uncover Ms. Robinson. She all of the unforeseen appeared and was surprised that the orders were now now not but entered. She went to the desktop and got every factor installed, and returned with an 11 page disclosure about the medical trial. It was NIH NCI Study No. thirteen-C-0016: Phase 1 take a look at about of adenoviral transduced autologous dendritic cellular vaccine expressing human HER2/neu ECTM in adults with tumors with 1-3+ HER2/neu expression. I started out reading inside the course of the disclosures when Ms. Robinson stated that Dr. Wood was obtainable to meet with me and explain a chunk extra about the trial.
Dr. Wood was joined by a team of five: a fellow, two medical students, and two nurses. She enthusiastically explained the intent of the trial. I situated that this was a prime-in-human trial for a new kind of custom designed immunotherapy. She explained how my cancer had validated positive for HER2 overexpression (the scan somewhat simply were plus 3). The HER2 protein sends signals to tumor cells to make them develop and combating the tumor from dying. HER2 overexpression has been studied extensively in connection with breast cancer, in which it too would be present in 25-30% of cases. The HER2 genome is responsive to a bunch of medications, together with trastuzumab (Herceptin), pertuzumab (Perjerta), and ado-trastuzumab emansine (Kadcyla), that are monoclonal antibodies that identify and inhibit distinct quantities of the HER2 protein. The medicines would wish to be administered again and again to have an end result, and that they do not essentially work on all HER2 cancers.
The medical trial is composed of the creation of a AdHER2 DC vaccine to induce the sufferer's possess immune supplies to make multiple, lessons of antibodies to HER2, referred to as polyclonal antibodies. Mammalian reviews have shown that a AdHER2 DC vaccine has caused vast regression and shrinkage of colossal customary tumors. A YouTube video of this trial is equipped right here. The goal of the trial is to set up if the vaccine that works in mammalian reviews too would be translated to human beings. Because monoclonal antibodies reminiscent of trastuzumab can adversely have an end result on cardiac feature in some patients, the FDA is requiring this trial to closely monitor cardiac feature.
I was informed that the trial may encompass the removal of certain varieties of my blood cells through a process referred to as apheresis, in which my blood is drawn, run through a cellular separator equipment to take out my circulating cells (together with lymphocytes and monocytes), and the plasma and red cells returned to my body. The circulating cells are then used to custom make a vaccine. Enough circulating cells are removed sometime soon of apheresis to make 5 or 6 batches of vaccine, using my very possess dendritic immune cells. Those dendritic cells are derived from the monocytes in my circulating cells. The NIH doctors may mix in a aggregate of trastuzumab, pertuzumab, and ado-trastuzumab emansine into that vaccine, then may inject it transdermally (under my skin). The protocol calls for five rounds of injections: weeks 0, four, eight, 16, and 24, to boot as two years of monitoring.
After attempting to digest all of this lend a hand, I went back downstairs for the CT scan. The tech was unable to get a return blood draw from my port, suggesting that there was a clot or different kind of blockage round the tip of my port. She was capable of inject heparin into my port, having stated that, so we used it for the injection of the contrast sometime soon of the CT scan. While wanting out ahead to my CT scan, I sent an email to Dr. Apolo, asking for her input on whether she thought that I ought to always enter this exact medical trial. After summarizing the trial, I wrote:
I am best involved by your recollections on whether I ought to always participate on this take a look at about, or as a switch join the 2 your PD-L1 take a look at about, or the MPDL3280A take a look at about, or some of some different trials that we had discussed. My initial impression is that, as the HER2 take a look at about is a prime-in-human segment 1 trial and the healing end result is unknown, it too would be extra useful for me to affix a PD-L1 trial as a switch. Or ought to always I take a stab at this, then do the PD-L1 trial later? Or vice-versa?
I left for family after the scan. I was informed that I ought to always plan on coming back to NIH the subsequent day for a bone scan, echocardiogram, and additional discussion of the trial protocol. I stopped at Chipotle on the means family, as I had now now not eaten since the nighttime before. While walking into Chipotle, Dr. Apolo referred to as me. She stated that she had informed Dr. Wood about me back in August, having stated that expected that Dr. Wood may have spoken with her before contacting me. She recalled that we had made up our minds to wait until my next scan on November 18 before deciding what course of treatment, if any, and appeared surprised that her colleagues had initiated contact with me a couple of tribulation. While praising Dr. Wood's revolutionary investigation with the AdHER2 DC vaccine, Dr. Apolo cited that it was a prime-ever Phase 1 trial, and there was no evidence that it may work in human beings. By contrast, the PD-L1 trials had shown vast response in extra than 50% of take a look at about individuals. She stated that, while it was effective to have possibilities on trials, she may recommend that, if I was to favor to enter a tribulation, she may recommend that I take part in a PD-L1 trial. She proposed that I defer for in spite of the whole lot per week my decision on whether to enter Dr. Wood's HER2 trial, and inside the period in-between Dr. Apolo may review the somewhat simply of contemporary CT scan, and meet with me on Tuesday, October 14. That sounded exceptional to me.
Five mins when i got family, I was referred to as by Dr. Wood. She stated that she had simply reviewed the somewhat simply of my CT scan. She stated that it showed an immense clot in a vein in my liver, and multiple clots inside the reduce lobe of my right lung — a serious case of pulmonary embolism, or PE. She asked me to promptly return to the NIH health center for management of blood thinners. She stated that I may be too would be inside the health center for a day or two. I briefed Jennifer, jumped back inside the Audi and went back to NIH. After I was admitted, I met with Dr. Wood, who had waited for my return. She explained that mets cancer patients were at increased menace for PE. She stated that the finest treatment too would be for me to have two subcutaneously injections day-by-day of enoxaparin (Lovenox). She stated that this was extra effective in patients with a cancer burden than IV-administered unfractionated low molecular weight heparin.
So now I'm reclining in my health center mattress staring at the Deadskins get thumped by the Seahawks. At round halftime, the nurse came if to inject the Lovenox into my stomach. She admired my love handles, and stated that they were preferrred for the injections. I smiled with the scoop that the decades of preparation for this day has finally paid off. I'll get a different injection the subsequent day morning, and then may be gets gifted on injecting myself. I'll ought to do the injections twice a day for a larger month or so, then too can have the capacity to shift to oral therapy. Whether by serendipity or a chunk of divine intervention, I'm grateful that the PE was detected without my discomfort any damage. It was (ahem) a stroke of nice luck.