Saturday 27th June, 2015

A week of our Clinical Trial.

UCSF Helen Diller Family, Comprehensive Cancer Center, Mission Bay. 
Three full days we have spent in the city.  

I can honestly say I have never spent so much time on the road driving in and out of the city.  And, of course, my driving is not quite as good as Johnny's.  Not a time to have a driving argument.  Once upon a time heading into the city was for fun.   Now it’s a need, a necessity and requirement. 

We cannot "fib" to you, it has been strenuous, since no chemo in May.  Johnny's weight has deteriorated significantly, I have lost count of the amount of butter, eggs full fat milk, cream added to his food. Weight gain is significant.  It's important.  The body requires fuel to fight.  Johnny's loss of appetite, requires me to become more  creative with meals. Tiny morsels at time it can take 40 minutes to eat a meal and then to not complete his plate.  With profuse apologies he pushes it away.  Its OK – eat what can love.  There is nothing he desires to eat.  The pain continues, to beat him down.   The narcotics, help relieve the pain, he has to take far too many, which in this case, leaves him befuddled with speech, slurry of words, enunciation, and absent mindedness. Over medication comes to mind, to which the doctor  lowered the dosage, having never met a patient on such a high dosage.  Johnny slowly moves, shambles around the house,  holding his stomach, with a brave face.  I wince, hard to see a strong man, my man, my husband my soul-mate, punished, whipped down to his weakest.   It is as though he is being hounded by a  masked executioner.  Johnny continues to amaze, he fights to live life.  He tells me he does not feel as though he has one foot in the grave, just yet.  

UCSF  Mission Bay, driving right through the city, chock-a-block with traffic, all of 90 minutes, is  challenging, to say the least.  Time of day, morning,  does not help.  But,  UCSF, a new campus,  clean modern and slick is exhilarating,  fascinating, new technology, dynamics of the doctors and nurses, swift check in questions, strong questions in need of the right answer to ensure Johnny is able to participate in the trial.  The desire to ensure Johnny is "comfortable". 

Tuesday 23rd June: Week 1-Day 1 - Doctors Consult

 Blood work is drawn, three tablespoons of it, in order to evaluate his general health.  We meet Dr. Tom Weber, who gently prods Johnny with questions, listening patiently taking notes.  He took his time, no rushed appointment, it was all about Johnny.  Caring and understanding.  One of the questions he asked "how are you feeling, are you up and about or lying in bed"?  to which I pipped in saying "are you kidding he has put in two skylights,  hardwood flooring, created a front courtyard, paved, with double open doors, new roof, new bathroom and now he wants to have new kitchen cabinets and change the granite, oh and yesterday he is hanging the hammock and a washing line".  Johnny proceeds to get his iPad out and show the doctor photographs, whom is suitably impressed.  "Well what do you do when you are not creating a home"?, "Oh I have a racetrack and race cars around the house".    Dr. Tom Weber says well in that case we are more than good to go, with a nod to the nurse.  I asked what did he mean?  Well,   "The last patient I had to turn away as he did not qualify for a clinical trial,  he was not active enough, he was in bed all day".   So my friends, that have seen our Johnny of late, it is a good thing Johnny is doing what he wants to, in order to keep his mind activated and stimulated.   Creating a beautiful home for me, the puppies and kitties.

Tuesday 23rd June: Week 1-Day 1 

Cyclophosphamide. Chemotherapy, a low dosage. It works together with the GVAX Pancreas Vaccine, along with a nice bag of saline to hydrate Johnny.  Side effects, fever, sweating,  we were up most of the night wiping him down changing the sheets.  Not much pain but still with some.  As he sleeps before our next appointment, (Wednesday), I checked in on him, curled up in a fetal position, bundled up in the white fluffy duvet, puppies buried within, wrapping themselves around him.  Rest my darling rest.  

Wednesday 24th June: Week 1-Day 2

GVAX Pancreas Vaccine.   Six point of injection sites are used: four upon each upper thigh, and two upon his left arm.   The injection sites requires the main points to be numbed for 45 minutes before injecting.  Once injected, the GVAX Pancreas Vaccine  sits under the skin surface a bit like the TBD injections we had as a kid in Great Briton.  The vaccine is a bubble of fluid and  disperses throughout the body gently.  We hope without any reaction.  No redness no itchiness, no scratching no swelling.   

Friday 26th June: Week 1-Day 3

Return to UCSF for evaluation and review any injection site reactions.    Currently there are none, thankfully, but we await the doctors consult. Our next appointment will be July 16th and 17th, for a repeat performance of the above and the CRS-207 drug.  Each day visit has been at least 5 hours. 

"In this randomized controlled Phase 2a clinical trial the combination of "CRS-207 with GVAX Pancreas",  demonstrated a statistical significant improvement".  

With love – Michelle & Johnny

Tuesday 16th June, 2015 - Clinical Trial

Good afternoon,
Friends and Family,

Today Dr. Andrew Co, from UCSF Cancer, called and confirmed:
Johnny has been randomized into "ARM A" for the clinical trial.
Good news this means he will receive the following: this is the main drug we wanted him to be on. 

Cyclophosphamide/GVAX Pancreas vaccine and CRS-207 over the following weeks:
2 doses of Cyclophosphamide and GVAX Pancreas vaccine, three weeks apart;
4 doses of CRS-207, 3 weeks apart;
total of 80 patients includes our Johnny
this trial is a total of 20 weeks.  Dr. Andrew Co. hopes this will help Johnny.   Know that this is not a cure it's helping Johnny. 
 
As a reminder:
GVAX Pancreas Vaccine, sponsored by Aduro Biotech. Only 240 people will be enrolled, from different participation centers. The GVAX pancreas vaccine is made from other patient’s pancreatic cancer cells.  The cells were changed in a laboratory to make a protein called GM-CSF.  This is done by putting the GM-CSF gene into the pancreatic cells.  A gene is a piece of protein (DNA) with a message on it that tells a cell to make something.  In this case the message is to make more GM-CSF than it would normally make.  GM-CSF helps to activate the immune systems cells to recognize and attack the cancer cells.  Because a gene was inserted into the cells of the other patient’s cancer cells to make this vaccine it is therefore called “gene therapy”.

Johnny has been having a miserable time, we both have of recent. 
Please keep sending you love and emails: johnnypye@yahoo.com he does enjoy reading them.
Regards
Michelle & Johnny

Thursday 11th June, 2015

Hello Friends and Family.

Thursday 11^th June, 8.45am, I am pulling into the office, car park.   UCSF Cancer hospital, pop up on my caller ID.  Sara, I ask “do you have a magic wand for me today, has my appointment for Johnny been pulled forward?”  “Yes I do have a magic wand.  Today at 11.45am can you do it”?  “Yes we can”.  

I run into the office send an email to my two bosses explaining the situation and run back to the car. Home bound to pick up Johnny, thinking to myself, I am going to have to push him, (it takes Johnny a long time to get ready, he potters, ponders and wanders), ready for the drive into the city to UCSF Helen Diller Cancer Center – Mission Bay.  All of a 90 minute drive.

Dr. Andrew Co and his coordinator, examine Johnny, along with a list of questions, in order to gain more background on Johnny.  More blood work and cardio examinations.  CT Scan Monday 15^th June, ready for UCSF to review on the 17^th June, for possible submission to commence the trial on Tuesday 23^rd June.   Remember, from my previous blog, (as per below), trials are strict, strict criteria.  From our last CT Scan in May, he had trace amounts of fluid in his abdomen.  Dr. Co is adamant, no acceptance into the trial if he has fluid.  It can’t be drained.  No other trials will accept Johnny if this is the case.  The other trial is a PARP Inhibitor Trial, but this works if Johnny has a certain “BRCA mutated tumor”.  The other alternative would be to go back on the first round of chemo that really put him through hell.  We both know he  can’t do this emotionally and physically.

To date, friends and family, Johnny has been in significant pain, it’s constant, always there, the pain never leaves, starts just below inside his rib cage and drops down past his belly button.  Sometimes moving towards the back.  It’s a typical pancreatic pain.  Always there, a sharp stabbing bayonet cutting, twisting and turning.  His weight has dropped to 125.  My Johnny is a skeleton of skin.  Intake of pain medications to relieve the pain has been critical of late.  He awakes me at 2am telling me he is in much pain, distress, in need of medication and comfort.  Level of pain these days is a 6-7.   It’s the cancer we are told.   The emotions, sadness, along with a feeling of “pure acceptance”, I see upon him is dire.  The pain, anguish, heartbreak of possibly leaving us, knowing he probably does not have long, he is trying to mentally put things into perspective.   Today was tough, exhausting, we are home, I put him in a lovely bubble bath, wash him, caress him, the puppies can tell, their master is really sick, they come to sit and watch over Johnny, he sees them and the tears fall, they drop, splash upon Squeaks nose, he licks his master's salty tears, as they fall spilling into the bubbles, as I bath  my darling Johnny, reassuring it will be OK, I am here with you, Bubble n Squeak are here.  Johnny is crushed, wounded, lost, empty and dejected.   We are at a loss.  

“GVAX Pancreas Vaccine, sponsored by Aduro Biotech. Only 240 people will be enrolled, from different participation centers. The GVAX pancreas vaccine is made from other patient’s pancreatic cancer cells.  The cells were changed in a laboratory to make a protein called GM-CSF.  This is done by putting the GM-CSF gene into the pancreatic cells.  A gene is a piece of protein (DNA) with a message on it that tells a cell to make something.  In this case the message is to make more GM-CSF than it would normally make.  GM-CSF helps to activate the immune systems cells to recognize and attack the cancer cells.  Because a gene was inserted into the cells of the other patient’s cancer cells to make this vaccine it is therefore called “gene therapy”.

With participation within a trial, it is accompanied by a 43-page consensus document, criteria, screen procedures and pre requisite requirements. A computer program will incorporate all of his data and place Johnny in one of the three “Treatment ARM(s)”.  It’s randomized, neither Johnny nor our doctor can dictate or know which Treatment ARM Johnny will be selected for.

Until then friends, we await for Dr Andrew Co’s approval or not.

Please send Johnny your love your funny stories what has been happening with you in your life. 

His email: johnnypye@yahoo.com

Sunday 7th June, 2015

Hello Friends and Family.

Tuesday 19^th May, Bobbie Head's office told us, our chemo regime of Abraxane and Gemcitabine is no longer working.  From examinations of the CT Scan the week before, the cancer has spread to Johnny's lungs. “Innumerable bilateral pulmonary cavities in his lungs which have increased significantly”.  “The lung walls have thickened, along with accumulation of fluid in his abdomen”.  Johnny's breathing is laborious, considerably so.

Chemo has been hell!  But without the chemo, Johnny would not be here.  The chemo was our army, killing the cancer on our behalf.  And, now with no more chemo there are no soldiers to fight on our behalf.  As, Johnny become weaker the cancer becomes stronger in the body.

No more chemo.  That is it.  Done.  The news was given with the greatest care, respect and sadness.  Dr. Lucas, head of Marin Cancer Care, was sincere with her kind deliverance.  

Again, not the news we wanted to hear.  Deep down Johnny knew, his body has changed, incredulous drop in weight, the slowest of movements, the feeling of cancer, the return of the heavy nightly sweats, the return of seven shirts a night, the numerous bed linen changes.   I awake at the slightest movement of Johnny, I watch how he awakes during the night, removes a shirt, wipes his body down with a towel only to put on a fresh shirt.  This is all done eyes closed, in mid, deep, sleep.   The pain has increased ten fold, dosage of medication, doubled and intake doubled/tripled.

What next?

Clinical Trial at UCSF.  

What is a Clinical Trial?  What does this mean you might ask?  It’s a study.   There are currently two clinical trials.  One we know of, is GVAX Pancreas Vaccine, sponsored by Aduro Biotech.  Only 240 people nationwide will be enrolled, from different participation centers. The GVAX pancreas vaccine is made from other patient’s pancreatic cancer cells.  The cells were changed in a laboratory to make a protein called GM-CSF.  This is done by putting the GM-CSF gene into the pancreatic cells.  A gene is a piece of protein (DNA) with a message on it that tells a cell to make something.  In this case the message is to make more GM-CSF than it would normally make.  GM-CSF helps to activate the immune systems cells to recognize and attack the cancer cells.  Because a gene was inserted into the cells of the other patient’s cancer cells to make this vaccine it is therefore called “gene therapy”.

With participation within a trial, it is accompanied by a 43-page consensus document, criteria, screen procedures and pre requisite requirements. A computer program will incorporate all of his data and place Johnny in one of the three “Treatment ARM(s)”.  It is randomized, neither Johnny or our doctor can dictate or know which Treatment ARM Johnny will be selected for.

Our appointment with Dr Andrew Ko at UCSF is scheduled for Monday 15^th June.   If not earlier.

Johnny wanted to go away.  Memorial Weekend.  I was set against, foreseeing health issues and struggles. But I have to allow Johnny to be able to live.  Cabo and sunshine beckoned us, shared with good strong solid friends.  Moments, cherished, building another layer of memories.  Our friends understand Johnny, understand his pain, his struggle.  They have shared the path together with Johnny.  Their patience, love and care makes Johnny feel loved.  Choosing carefully restaurants Johnny would like, only to change the timing for Johnny at a moments notice in order for Johnny to rest more.  Chilled moments poolside, cocktails and laughter.  For one split second it was a normal day.  Holidaying with friends.

United Airlines were superb. We had wheelchair access throughout the air trip, pre-boarding with excellent seats.   Once landed in Cabo, a turbo charged wheelchair met us at the gangway.  Whilst seated, Johnny looked down at the ground, before looking up at me saying "Is this not for old people"?  "Sit and relax honey" was my response.  We bypassed five plane loads at customs,  immigrations forms were completed on our behalf and in a taxi headed to our hotel.  From what could have been a 90-minute wait at immigration, turned into a 10-minute trip, from landing, immigration and taxi.  Superb.   No wait, no line, no silly questions.  All paperwork was done for us,  out and back to San Francisco. Lovely.  

Until then friends, we await Monday 15^th June at UCSF.

Please send Johnny your love your funny stories what has been happening with you
He would love to hear from you.  His email: johnnypye@yahoo.com

With love and tears

Michelle & Johnny

Five years ago tomorrow - 5th June, 2010 I married my darling Johnny.  It took a while, but he finally put a ring on it!  Johnny you are my true love, my best friend, my inner sanctuary, my husband my darling Mr. BooBoo.   

You "complete" me, through and through.    

Please raise a glass and toast to Mr & Mrs Johnny Pye.

Our oncologist has informed us that the chemo is not working.

Our hope is that his body will pass the criteria for a clinical trial.

It is now

Johnny vs Cancer

The final frontier