Trial Tribulations

Last night Jen began a new round of chemotherapy.  Even though resuming chemo was both Jen's and my gut instinct for how to proceed, in reality we didn't have a lot of options.  Since her last scan we have been pursuing the clinical trials that might be open to her.  This process was a lot more problematic than we had believed it would be.

Jen's most recent scan was her first recurrence.  Usually most trials for glioblastoma are targeted for first recurrence with a growing number available as upfront trials (meaning upon diagnosis).  At the time of Jen's initial diagnosis in 2014 there weren't any readily available upfront trials that she was qualified for.  This probably turned out to be a good thing as she was instead able to use the Optune device which we believe has made a difference at least up until now.  Some trials can be undertaken at later recurrences (second, third, etc.).  Each recurrence means growth following another intervention.  Even if the chemo that she is currently on does not slow the growth, she may no longer be considered at first recurrence and may fall under second recurrence.

We tried to focus especially on trials targeting first recurrence as we are presently at a unique opportunity that may not be available again.  As I have previously indicated, Jen is excluded from a sizeable number of trials because she didn't have surgical resection and because she is multi focal (multiple tumor expressions).  Most trials want to have the best chance of success and will often limit themselves to patients who have had resection of a single tumor.

There were still other trials worth pursuing though.  We contacted a wide variety of medical institutions to see what Jen would qualify for.  Most came back with only 1 or no options available to her and many we have yet to hear word from.  Of those we did initially qualify for, many we ruled out simply because the ramp up time would be too long.  Some she probably wouldn't be able to start for weeks or as much as a month.  Glioblastoma is extremely aggressive and we feel that is too long to wait.  Glioblastoma can double in size every 2 weeks.  For a slower growing tumor these options might be worth considering or if Jen didn't have any other options (if she hadn't initially had a good response rate from her chemo).  Others we ruled out because they could be utilized at multiple recurrences or because the methodology was very similar to other trials that have not produced spectacular results.

The final trial we were considering versus chemo was ruled out on Tuesday afternoon because Jen didn't have enough tissue sample to qualify for the trial, even though she was eligible in every other way including possessing a required genetic marker in her tumors.  Whenever  a biopsy or resection is performed the tumor cells are preserved.  This is done for genetic testing as well as to allow for further testing for various clinicals down the road that may request tissue samples.  Someone who has had a resection usually has a fair amount of tissue that is preserved.  The amount is significantly less with a biopsy.  Also a fair amount of what is removed in a biopsy goes towards the initial testing for the cancer itself.  This particular trial wanted a higher than usual amount of tissue for it's research, exceeding the total of Jen's stored tissue.

Other drugs that we were interested in pursuing are not even available for Jen to try, even if we argue for compassionate use.  There are a few that could be pursued off book, but since they are not currently approved for Jen's condition insurance will not pay and we would be looking at tens of thousands a month in medication costs.  All in all, out of all the available options, resuming chemo seems to be her best current option.  Statistically it also should have a higher probability of further helping than any other available treatment.  If there were a readily available first recurrence trial that Jen could have participated in with an imminent start date that had a methodology that we strongly believed in we may have gone that route knowing that chemo could always be resumed if the trial didn't work for Jen.  On the other hand another course of chemo for as long as it may work is probably the option with the best chance for immediate success.  With brain cancer, growth often comes with additional deficits, so our goal isn't just maximum time, but maximum time with the best quality of life.

We obviously hope that the chemo works again for Jen this time.  We want to keep buying as much time as we can, not only so Jen can continue to live a rewarding life, but also so that hopefully new options will become available.  In the meantime, we are also tracking forward with a particular trial out of City of Hope that is extremely interesting in it's approach.  This is one of the trials that can take about a month to begin.  We are hoping to initiate that process and move forward as much as possible so that if the chemo doesn't work we can possibly consider it as an option.  We are also setting up an appointment with a neurosurgeon who is one of the best in the country and has looked at Jen's scans and believes she could remove some of the area of new growth.  This would not be undertaken solely for removal as too much would be left behind to warrant the surgery for it's own sake, but this may be a path necessary to qualify for surgical trials that may become available.

For me personally, this process has been rather frustrating.  Jen had her scan on a Thursday afternoon.  Nothing could even begin in terms of contacts until Friday morning.  Then came the weekend.  Even though Jen's cancer doesn't take the weekend off, all the doctors and medical institutions essentially do other than essential services.  I felt this same lack of inertia when Jen was in intensive rehab and Jen arrived on a Thursday, on Friday she only got evaluated, she received a couple of hours of PT on Saturday, and then nothing again until Monday.  Too much lost time.

I thought we would have a hard time choosing between at least a dozen options and in the end, I felt that we really didn't have many viable choices.  I have heard from several people over the years regarding various trials and people assume that a trial that appears to be working for 1 patient will automatically work for another with the same condition.  This is not actually true and just because there is a trial or a drug that you would like to pursue, you may not be able to.  One of Jen's doctors told us to remember that clinical trials aren't really about helping patients, they exist to answer a question.  Hopefully patients will benefit as well.  The scientific side of me understands and gets this, but as the husband of someone suffering, I don't like it.  I wish there was an easier way for us to get to try a few of the therapies I have been following since Jen got sick that seem to be showing at least some promise.

So what is next?  Jen will be continuing the chemo on a cycle of 5 days on, 23 days off.  We will hopefully be able to keep going with this for the near future.  That is the ideal.  Jen's next scan will be in 3 weeks from tomorrow.  Then we will know if the chemo is having any impact.  If it is at least holding the cancer, we will continue with another chemo cycle, if it does not, hopefully we will have at least a few options worth considering.  In the meantime she is continuing with the Optune and her Ketogenic diet.  Jen has an amazing attitude and I am constantly in awe of her resilience, and the grace with which she has undertaken all that she has been up against.  Her spirit certainly helps to buoy mine.  As always, we welcome all the positive prayers and well wishes that come our way.