The Duke clinical trial - Qualifying for the Trial

John decided he wanted to be aggressive in pursuit of solutions to his GBM.  It is such a daunting diagnosis solely depending on the standard of care did not seem prudent. The challenge was identifying and qualifying for a suitable trial.  Trials by their very definition are experimental. You hope for a beneficial result but there are no guarantees. However, he didn't want to just stand by and miss a chance for some improvement. The team at Pinnacle helped us cut through the swath of trials that are in flight throughout the country. After some review John decided to target one for which Duke was a lead site. This trial employs Avastin, in combination with the standard of care, for patients who are newly diagnosed with GBM.  The trial details are at : http://www.clinicaltrials.gov/ct2/show/NCT01740258?term=GBM&recr=Recruiting&state1=NA%3AUS%3ANC&rank=24 for those interested in the nitty-gritty details.

We descended on Durham Sunday, Feb 10th arriving at the hotel  well after midnight.  Though I had visited Raleigh many times for work at previous companies I had never made a trip out to Durham. On the drive to the hotel in Durham, I received a hard time from Melanie and John for not just "knowing" where to go after so many previous NC trips! I had forgotten how little highway lighting there is in NC.  It makes exits off the highway feel like a quick turn onto a trail into the woods!

Monday morning we were up bright and early for an 8:30 breakfast meeting  with the  Pinnacle Health Care SE region representative, Gina.  She shared how the day would likely go with the Duke team. It was the cavalcade of presentations, tests, discussions, training, and review that she forecasted.  In particular, the discussion with Dr. Henry Friedman, who is taking John on directly as his patient, while short, was very positive. It was clear that the attitude of striving to beat this cancer, which permeates the discussion with all of the team, starts at the very top with Dr. Friedman. 

Over the course of Monday and Tuesday, John qualified for this  newly opened trial. I cannot express what a relief this was to all of us.

Because the schedule for the visit was rather open ended (picture a team of busy doctors, nurses, and researchers trying for a time slice to meet with John, wrapped around their pre-existing schedule) we committed to two days on the ground at Duke.  As it turned out we ended up having most of Tuesday to ourselves as we crammed everything we could into the shortest period of time.

Monday evening we met a great friend of mine from the MMC Networks days, as Leonard Bush and his wife Amy joined us for dinner. Leonard, many, many years ago, took me to a AAA ballgame featuring the hometown Durham Bulls,  a team made famous in the film Bull Durham.  Monday night we enjoyed some fine Carolina BBQ at Tobacco Road Sports Pub, situated atop the left field wall at the home of the Bulls.

Having the late flight Tuesday we ended up with a bit of free time before departure and, knowing we were looking at an evening of airline/airport food, we leveraged another eatery tip from Leonard. Yes, we had  more BBQ, this time at The Pit. We can definitely recommend both restaurants.

We had a largely uneventful flight home with the exception of an hour delay in Vegas leading to another post-midnight arrival. The next day brought the start of his chemo and radiation therapy treatments.

PS : An interesting statistic we picked up during the course of the trial review was that while there is almost always a trial or even several trials ongoing at any time for just about any cancer you name, only somewhere between 3 to 5 percent of cancer patients avail themselves. There are many considerations in participating in a trial, including some John will experience through this trial, but that percentage seems so low, it is hard to understand. 

What's happening with his cancer treatment?

This initial post will cover the latest state of John's cancer treatment including the clinical trial he has joined through Friday, February 15th.

Quick recap of how we got here:

1. Dec 27th, 2012 John had a seizure while getting ready to play a pickup football game. His friends Lawrence, Ricky, Michael and Willie Jo, and Austin quickly call 911 and then Melanie. An overnight at Good Sam hospital revealed the presence of a mass on his right frontal lobe.  The neurosurgeon, Dr. Ali Shirzadi, informed us that it will have to be removed and biopsied.
2. Jan 3rd, 2013 the mass is removed. John comes out of the operation in great shape but the preliminary diagnosis is a tough one: Glioblastoma Multiforme, stage 3 or 4. The biopsy results are preliminary and are sent out for a review.
3. Jan 10th the diagnosis is confirmed as GBM, stage 4. The result is we begin our battle with this cancer.

Through the weeks since the diagnosis till now, Feb 15th, we have met with many wonderful doctors including Dr. Peddada (Radiation Oncology and the first to detect the source of this cancer), Dr. Elwyn Cabebe (Medical Oncology at http://www.vmoc.com AND SI Wildcat Class of '92),  Dr Jennifer Clarke (Neuro-Oncology at UCSF), the aforementioned Dr. Shirzadi and recently  Dr. Henry Friedman (neuro-oncologist and co-director at the Brain Tumor Center at Duke) to discuss John's treatment.

All agreed that the surgery was an excellent procedure and that the location of the tumor was overall fortuitous. Also all agreed that his age and health condition are strongly in his favor.  We learned last week that the possibility of it being the most aggressive form of GBM, with EGFR- Viii cell marker present, was eliminated via cell testing.  However, GBM remains one of the most challenging cancer diagnoses a person can receive. 

The standard of care treatment for this disease is a 6 week treatment of radiation therapy combined with the use of a chemotherapy, Temodar. It starts in a 4-8 week window following surgery. This treatment is under the direction of Drs. Peddada and Cabebe.

During these past few weeks John decided that he wanted to pursue as aggressive a course of treatment as possible, including joining a clinical trial if one could be identified. One of the dilemmas of many trials is they often are randomized, double blind which means no one knows if they are receiving a novel medication or a placebo. Thus in mid-January we were excited by the possibility of John's inclusion in a trial of a beta-protein inhibitor run out of UCSF. If selected, and 3 out of 4 applicants will be, he would be guaranteed to receive the drug. Unfortunately, in the lottery he drew the short straw. The only other trial at UCSF was one for a vaccine to address EGFR-Viii.  We hoped to avoid this trial as it was a double blind trial, however, if one has that cell marker you really need the vaccine as the disease is very aggressive. Even a 50-50 opportunity would be better than just receiving standard of care.  Fortunately that choice was eliminated by the negative results for the cell marker mentioned above.

This left the question of which trial to pursue. There are a ton of trials out there but no meaningful information for a laymen to confidently use when selecting amongst them.  In the end, we opted to work with a health advisory firm, Pinnacle Health Care Management, to navigate the decision tree. They've done that and more for us. They helped us understand the options offered at different research centers, understood our desire to be aggressive within the bounds of John's quality of life considerations (think a trip to Hawaii at last), and facilitated discussions with various leading oncologists around the country.

In making this kind of choice there is no right or wrong answer - the game is played at the very edge of our understanding of the disease and what options can be brought to bear without compromising one's time on Earth.  But we knew that John wanted to play this game hard so we were drawn to, and ultimately chose to participate in, a trial involving a well known cancer drug Avastin (thumbs up to the team in Emeryville at Genentech), being run at Duke's Brain Treatment Center (http://www.cancer.duke.edu/btc/). Avastin is a drug that has been used beneficially to treat a number of cancers, including GBM.  Beneficially, particularly in the case of GBM, means to prolong life, but GBM remains a difficult disease to ever declare defeated.  It's FDA approved use in GBM cases is for the time a tumor has recurred.  The trial is to determine its effectiveness in treating newly diagnosed patients such as John.

We flew to Raleigh, North Carolina on Sunday, February 10th.  Over the course of the next two days John met with and enrolled in a Phase II trial to test the effect of Avastin on newly diagnosed GBM.  In the first cycle of the trial John receives Avastin every two weeks for six rounds of treatment.  The treatment is provided by his local oncologist, Dr. Cabebe.

Treatments started on Wednesday with radiation and the Temodar. Temodar is taken as a pill. Radiation is given Monday through Friday for 30 treatments and Temodar is taken during this same period but everyday.  John received his first Avastin infusion Friday the 15th.  Thus far he has tolerated everything well. We hope that continues to be the case for the duration of treatment.

Once he gets through the radiation treatment he will continue on Temodar. The dosage level will change and the cycle of dosing will become a five day dosing window followed by twenty three days off then repeat.  Avastin will continue throughout every two weeks. He will receive another MRI at the beginning of April.

As part of the trial John has to return every eight weeks to Duke for review. His next visit is slated for April 9th. We hope to attend a Durham Bulls vs Gwinnett Braves Triple-A game while we are there. It is the Bull's Opening Week of baseball. We will also indulge again is some of eastern Carolina's excellent BBQ.

So that's the story on treatment thus far.  I will post some information later on the genetic basis for his GBM illness.