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[cancer|science] The study in which I have enrolled

I now have permission to talk in such detail as I am capable of about the Phase II clinical trial in which I have enrolled at the National Cancer Institute at the National Institutes of Health.

The study is number 10-C-0166, “A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Digestive Tract Cancers.” The principle investigator is Steven A. Rosenberg, M.D., Ph.D. of NCI.

This is a immunotherapy study. Immunotherapy, as previously discussed, has been my preferred treatment modality for a clinical trial. Many if not most clinical trials for cancer are focused on refinements or new developments in chemotherapy, but in my case, chemotherapy has only ever been moderately effective at best.

There’s a class of white blood calls called tumour-infiltrating lymphocytes, or TILs. These are healthy cells from the body’s immune system which can be found inside of tumors, but in an inactive state with respect to immune response. Loosely speaking, what this study does is harvest TILs from one of my tumors, grow them in a lab to volumes many orders of magnitude larger than they would normally be found in my body, return them to my body and activate them pharmaceutically. The general idea is that these TIL cells, which already know how to find their way into the tumor tissues, will return in those fantastically larger numbers and halt tumor growth as well as inducing shrinkage.

It’s an approach that apparently works well in the mouse model, as well as in the petri dish with human cells.

This has been tried on human subjects with advanced melanomas to a reasonable degree of success. That was the initial phase of this trial. The trial has since passed in Phase II, with a larger melanoma patient cohort, but the investigators have also added a gastric cancer cohort. I will be the first metastatic colorectal cancer patient in the trial, though they have seen significant success with a closely related cancer.

While I was at NIH last week, I underwent apheresis to harvest white cells for the TIL growth medium.

I have now been formally scheduled for a thoracotomy on January 23rd. I will be flying back to the DC area on January 21st to be admitted to the NIH hospital for this procedure. The thoracotomy will probably be a wedge resection, though the teams have not finalized which lung. I have candidate tumors in both lungs, but there’s trade-offs to each approach. The left lung has a better tumor from their perspective, but the surgical team is concerned about possible adhesions and scarring from my 2009 left thoractomy. The right lung has an adequate candidate tumor (two of them, in fact), without the potential complications.

Once the tumor tissue has been harvested, it will be taken to the laboratory where TIL cell extraction will take place. TIL cell growth to the required volumes takes at least three weeks, sometimes longer. This means that around or shortly after February 13th I will begin my TIL cell infusion process.

In the mean time, I need to recover from the lung surgery. Once they have gauged the growth rate of my extracted TIL cells, the doctors will confirm a target date for the infusion process. I will actually return to the hospital about eight days prior to that target date, possibly as little as a week or ten days after my post-operative discharge. There is a seven day non-therapeutic chemotherapy process which I must undergo with the specific intention of wiping out my immune system in preparation for the TIL cell infusion. This will result in me being profoundly immunocompromised for a while.

That in turn means the TIL cells will be essentially the only thing working in my immune system at the time of infusion. I will receive them for one to five days, depending on my response, along with helper drugs to facilitate both their growth and survival. I will then spend about another two weeks in the hospital while my immune system recovers.

I will return to Maryland periodically for follow-up assessments, perhaps once per month. There is no set end date for this process. The investigating team will continue to monitor me so long as positive results can be identified — that is to say, tumor shrinkage without a significant rebound of the growth rate.

This is a “one shot” treatment, though results can manifest for months, even a year or more, if it is successful. The list of risks and potential side effects is frankly frightening. That is in part due to the complex of multiple drugs, each carrying its own list of issues. I will be very fatigued for weeks afterwards, and may have trouble with my immune system for some time to come.

This is also a pretty low probability effort. Only about a dozen gastric cancer patients have been exposed to this protocol. Desperate measures, if you will, for desperate times.

On the other hand, this is Very Big Science. The cutting edge of cancer treatment, at the most prominent biomedical research organization in the world. I’m not going to get much better than this.

I’m excited about the possibilities for my health. I’m excited about being part of Very Big Science. I’m excited knowing that whatever happens to me, this study could eventually help treat or even cure untold numbers of cancer patients. As awful and deadly and sobering as my cancer journey has become, this is also cool.

Like I’ve said before, the war was lost a while back. We’re just still fighting battles because I have been too stubborn to die. With any luck, this battle will buy me another six months or a year on the front lines.

It’s expensive. Lisa Costello, Dad and I have spent just under $9,000 out of our collective pockets already simply to get me to this point — that was the cost of our two weeks at NIH, including airfare, hotel, rental car and food. NIH provides some reimbursement, but it offsets less than 10% of that cost. We’ll spend about that much again over the next six or seven weeks as I transition through the stages of this clinical trial. Shortly I’ll be passing the hat again, though I’m going to need some help to set that up. Watch this space for details.

Meanwhile, this science fiction writer is diving into Very Big Science to try to stave off death a little longer.

Thank you for coming along even this far.

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