Wednesday, August 30, 2017

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.

Friday, August 25, 2017

Some bad news

We have unfortunately had some bad news with Jen's latest scan from yesterday.  The largest of Jen's tumors has doubled in size since her previous scan.  As you can imagine, this has come as a gut punch to both of us and we are still trying to process everything.  The irony is that we have been worried at various previous scans, but we were both feeling comfortable going into this one.

So what does this mean?  Jen is now considered to have her first recurrence (meaning first sign of new or growing tumors since beginning treatment).  There are not a lot of options for brain cancer patients, but we do have a few to consider.  Option 1 is resuming chemotherapy.  Although we probably won't get the benefit we did from the first round, there is a decent chance that this will buy some additional time.  Option 2 is to pursue a clinical trial.

The world of clinical trials is an interesting one and there are various exclusion and inclusion criteria for each trial available.  The fact that Jen didn't have surgical resection unfortunately rules her out of consideration for quite a few trials, and the fact that she is multi focal rules her out of many more.  But hopefully there are still a few that she is eligible for that we can consider.  Many clinical trials today are also based on the specific genetic markers that may or may not be present in an individual's tumor.  Jen's neuro-oncologist at UCLA is gathering a list and reaching out to the directors of various clinical trials to see what she may be eligible for.  We have asked him to consider trials at any facility, even if it involves significant travel, so he is reaching out to colleagues and researching available trials at other institutions throughout the US.  We will talk again on Monday after he has had a chance to hear back and gather the info.  Unfortunately, we have the weekend to get through or we would know more sooner.  We have also scheduled an appointment with another doctor out of the John Wayne Cancer Institute who has a great reputation, to get a second perspective.  We have also ordered the next round of chemo in case she pursues that option and I have arranged to have it overnighted so that she will have it on hand in case we decide to start on Monday night.

There are 3 phases of clinical trials.  Phase 1 is largely about finding the maximum tolerable dose of the given medicine and determining if it has a negative toxicity.  Obviously there are inherent risks to this.  The polio vaccine trial out of Duke that was featured on 60 minutes is a good example.  In the phase 1 - several patients died from receiving too high of a dose.  They ended up dialing it back for the Phase 2 study.  A Phase 2 study is really about determining efficacy.  Most cancer trials prove to be ineffective, but even then, sometimes a small population within the trial may have positive results.  A Phase 3 study casts a much wider net with more patients involved and usually multiple medical facilities.  Most also introduce a control arm to determine the real effectiveness of a given approach.  This means that you would only have a 50% chance of actually receiving the given therapy.  The other 50% of patients may receive a placebo.

Some of the clinical trials for which Jen may be eligible will require additional surgery.  Although her tumors can't be removed, they might be able to get a large enough section to qualify for various clinical trials.  Obviously any potential trials that require surgery to qualify will have to be weighed against the added risks and possible complications that may result from a second craniotomy.

It is also difficult obtaining a lot of information about ongoing clinical trials to determine which ones might be the most promising.  So it can very much be a crap shoot.  Also, entering a trial can take some time - anywhere from a week to as much as a month before actually beginning treatment.  This must also be weighed as presently Jen's cancer is growing and can grow rapidly.  We want to begin attacking it with something different as soon as possible.  Lastly, if Jen pursues a clinical trial she will have to abandon her use of the Optune device she has been wearing for almost 3 years.  Even though her cancer has grown, it is possible that without being on this device it would have grown even more, and she may still be deriving a benefit from the device.  Also even at first recurrence, continuing with the Optune still has a proven positive effect in buying additional time that may be absent in any given trial.

As I have said, we will hopefully know more on Monday and will be better equipped to make a decision about how to proceed.  The reality is often when considering clinical trials, you are making very serious decisions with very minimal info on the likely results.  On the other hand, if there is a significantly prolonging treatment or even possibly a cure, it does not exist in the current standard of care, but may amongst the existing clinical trials.

Although this is a serious hit, we are trying to take it in stride and remain positive.  Jen is in this fight for the long haul and despite the blow, she is ready for the next round.  Tomorrow marks Jen's 3 year anniversary since diagnosis.  Something that only between 10-20% of glioblastoma patients ever live to see.  Jen has already beaten the odds and she is ready to continue to do so.

Thursday, August 17, 2017

A long overdue update

I know it's been a while since I posted anything and would like to update everyone with how things are going and what Jen and I have been up to.

Jen has had two small seizures since I last posted.  The last one was about 3 weeks ago and the previous one was about a month prior to that.  These were both small and although we would prefer a longer period of seizure free activity this is a great reduction from the cluster that she had around the time of her last scan and we are grateful for that.  Jen has also resumed Physical Therapy.  This isn't due to greatly increased deficits, but there are a few bad habits that Jen has gotten into with her gait as a result of constantly wearing an AFO to correct her drop foot as well as always carrying around a backpack for her Optune device.  We have to always be judicious about how we use her PT, as to not go over the insurance allotment for the year.  This will especially be important if she ever has cause to go back in for surgery as she will need intensive rehab after.  Jen's next scan is coming up on the 24th of this month - only 1 week from today.  This will be the longest period yet between Jen's scans at 10 weeks.  As always, please keep Jen in your thoughts and prayers.

As you are all aware by now, Senator John McCain was recently diagnosed with brain cancer.  What you may not realize is that he also has glioblastoma.  The same type of brain cancer that Jen has.  One of the members of our brain tumor support group forwarded me an article written by a fellow glioblastoma survivor.  He particularly highlighted a couple of sentences from the article that he found especially moving.  I agree and share them with you as well.

"The element often lost amid the high-tech therapy is patient power. It is patients’ actions, knowledge and strength that, in tandem with world-class scientists and supportive public servants, will find a way through. ...  I imagine most people feel a surge of pity for Mr. McCain. I do, too. But I also feel something more powerful: solidarity. I wouldn’t wish membership in this club on anyone, Senator, but now you’re a member, you’ll find the warmest of welcomes."
 The full article can be read here:

As Lindsey Graham said in response to news of John McCain's brain cancer diagnosis. "This disease has never had a more worthy opponent."  I would have to agree, but then again, Lindsey has never met Jen.

A quick reminder to those in the LA area.  Jen is undertaking a walk for brain cancer on Nov. 11th.  We will post details very soon, but in the meantime would like to alert everyone in the area who would like to walk with Jen to keep the date open.  It will be a morning walk and should be finished by early afternoon.

This week also marks 30 years that Jen and I have been together!  We met at a mutual friend's Birthday Party going to a dance club and have been together ever since.  As I have mentioned previously, Jen and I are avid music fans and the summer is the biggest concert season - so we have been to a few shows recently with some of our friends.  We also took a daytrip to go wine tasting and hit the beach.  Now for some pictures.

Our first concert at the Hollywood Bowl this year.  We saw Queen.

At the Queen show with Jen's old boss John and his friend Lynn.

At the Greek theater with Tom.  Seeing one of Jen's favorite artists - Nick Cave.

Nick Cave.

Back to the Bowl for Dudamel conducting Beethoven's Ninth.

Getting away for a day to wine country.

After wine tasting we headed to the beach where Jen & I walked for about 2 miles.
Jen is trying to get ready for the 5K I mentioned earlier.

Alt-J at the Shrine.

Our friend Tim and us at the Alt-J show.

And lastly we caught Steve Earle at the Troubadour this past weekend.

Jen posing with Steve Earle.