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Jay Lake
Date: 2013-12-01 07:50
Subject: [cancer] Working through the universe of clinical trials
Security: Public
Tags:cancer, death, family, friends, health, personal
[info]mikigarrison, Dad and I spent much of Friday working through questions and decisions about clinical trials. Miki and Janet Freeman-Daily had been trolling online resources from NIH and elsewhere looking for possibilities, and diving through my medical history with Dad to try analyze how I matched the qualifications.

There are several issues right up front with qualification matches. One is that I have survived so long with this cancer that I have pushed through every available, approved treatment. This in and of itself disqualifies me from some trials, as they can have a matrix of "must not have been treated with X", or "must have experienced outcome A when treated with Y". While I am not flatly unresponsive to chemotherapy, my cancer has been pretty darned refractory. Another issue is my mutation status, as discussed here before. I have a rather rare KRAS mutation, which means that I am ineligible for studies seeking only KRAS wild type patients, but I am also ineligible for studies seeking only KRAS mutated patients, as my mutation doesn't correspond to any of the handful of recognized types.

There are other qualification filters as well. For example, my ECOG score (roughly speaking, a measure of baseline health and fitness) is relatively high for my disease history and duration. Perhaps unusually so. This makes me more fit for some studies than the average patient.

It's also the case that the intersection of my survival time, treatment history and mutation status put me in a very small pool of patients, for which many studies will not have an interest as people in that pool are rare enough as to not be worth targeting with research dollars.

Of course, we have our own selection criteria. Studies which have very low probability or unknown outcomes are less interesting to us than studies which are focusing on refining understanding of a known potential outcome. (I'm probably saying that wrong from a clinical perspective, but you get the point.)

Travel time, and time spent away from home, is also significant. I don't mind running off to the NIH in Bethesda, MD if I need to, but I can't spend months there as an in-patient study target. In principle, I could spend months here in Portland, or even Seattle, as an in-patient study target, because of proximity to my friends and family, and especially [info]the_child. Even there, the nature of the study inflects how we view travel. For example, a study which leaves me severely immunocompromised presents different challenges from a study which leaves me severely fatigued.

Location is relevant in other ways. NIH studies can be two or three years ahead of university and hospital studies in terms of the currency of the research being leveraged. NIH studies also usually include a travel stipend, which is otherwise quite rare. So I could go to NIH without having to spend a lot of money (or do a lot of fundraising), where a similar study at Johns Hopkins in Baltimore would have travel costs coming entirely out of my pocket (or those of my friends). I frankly don't know yet how much, if any, of this my health insurance carrier will pick up, as there's no point in asking them until we've got a better handle on what we're asking for.

We're also quite interested in treatment modality. Per [info]mikigarrison, there are four main cancer treatment modalities being explored in clinical trials these days:
  • Cancer vaccines

  • Monoclonal antibodies

  • Immune system re-engineering (using apheresis to harvest a specific type of immune cell (which varies on the study), genetically modifying the cells to turn the immune system on against certain tumor antigens, and re-infusing them into the body)

  • Anti-metabolite or otherwise cytotoxic drugs (newer drugs or drug combinations in line with what we think of as "traditional" chemo medications)

As it happens, I have extensive experience with anti-metabolites, to small effect except for my six successful months on Regorafenib, the drug which has now failed for me. I have modest experience with monoclonal antibodies, to no particular success. So in principle, we're a lot more interested in trials of immune system re-engineering techniques or cancer vaccines, reasoning that if the other treatment modalities have failed me, it's worth trying one with which I have no prior history in hopes that will be more effective.

As you can see, there are a number of overlapping selection criteria both from my perspective and the perspective of the study recruitment process. This means there is no clear-cut decisioning process or stack ranking for preference. Rather, everything falls into a matrix of factors, from which we have to make judgment calls.

At this point, looking within my somewhat narrow range of qualifications, we've found one Phase 3 clinical trial of a drug which has a strong response history for my kind of cancer. Issues there are the trial may be closing down, meaning I've missed the recruitment window, and that as a Phase 3 trial, it has a placebo arm into which I am at risk of being selected. Also, this is an anti-metabolite treatment modality. We've also found three different Phase 1 trials at NIH (Phase 1 trials do not have placebo arms), two of which are anti-metabolite trials, and one of which is an immune system re-engineering trial. Miki and Dad are working on a short list of other trials for us to pursue, most or all of them at institutions here in the western United States.

None of these trials are in Portland, but the next available trial in Portland which holds any promise for me doesn't open before February at the earliest. That's a long enough time frame for me to seek and enter another trial, and if I fail out of another trial, still be on deck for the that Portland trial.

Like almost everything else connected with my illness, this is a complicated and time-consuming process. I am profoundly grateful to my friends and family who are willing and eager to invest their time and energy in helping sort this out for me.

Also like almost everything else, the process is uncertain. I might be on the phone this week with an opportunity to go be screened somewhere for intake right away, or nothing might happen for weeks and weeks. So I can make no plans or commitments with any confidence at all.

We just keep trying, because that's what we do around here. When I'm too exhausted or overwhelmed to keep with the trying, others carry my flag for me a while.

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User: twicet
Date: 2013-12-01 18:38 (UTC)
Subject: (no subject)
I am amazed at the depth of work you and family, have put into all of this. The self-education alone, is staggering. I am a retired nurse, with a wide range of experience, and I'm not sure I would even know where to start with all of this.

I really hope you can find a trial that fits for you.
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Jay Lake: cancer-skull_tattoo
User: jaylake
Date: 2013-12-01 18:48 (UTC)
Subject: (no subject)
It staggers me, too, and makes me wonder how ordinary people cope with this. I have several advantages:

1) A disease moving slowly enough for us to research and react to changes

2) The privilege of good education and (relative) economic security, along with good insurance coverage, and longtime business and professional experience to prepare me to navigate the labyrinths of insurance, treatment, and so forth.

3) The further privilege of having some very high powered friends and relatives to support and lead me in this process. For example, my personal team includes a retired ambassador and a working medical school professor, as well as a biomedical journalist, a data librarian, and a retired engineer. People who know paperwork, process and research very well, in other words.

Thank you for the good wishes.
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User: martianmooncrab
Date: 2013-12-01 21:45 (UTC)
Subject: (no subject)
the paperwork maze at this point must be beyond the norm too... hoping for good outcomes close by for you.
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User: keikaimalu
Date: 2013-12-01 22:05 (UTC)
Subject: (no subject)
I wish you great good luck in finding a trial that helps you. Personally, I'm rooting for immune system re-engineering, because that avenue has always sounded very promising to me. Regardless, I hope you find something that helps you.
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