answers, I hope

Now that week 1 of Dave’s clinical trial is ending, I will try to answer some questions we have been asked by others.   First, this is a stage 2 trial.   In a stage 1 trial, the safety of a treatment is tested, then in stage 2 a low number of people are tested, often at different dosage, to determine the effectiveness of the treatment.   In this case, the plan is to get 90 people at the 6 sites around the country.   Once again we are in the right place.   Not only are we at one of the sites, but it is only 15 minutes away.   Two thirds of the people will be doing what Dave is doing and one third will receive only low dose chemo and the vaccine.   Dave’s group gets the low dose chemo and vaccine for two sessions, and then the last form sessions involve the infusion of an altered form of the listeria bacteria.   Both treatments are designed to kick start the immune system.   The trial is planned to last 20 weeks. 

It is clearly stated that a person may drop out at any time for any reason.   If the scans or blood work show the disease is spreading the doctor might suggest the use of a more conventional treatment.   If this level of the trial is helpful, a stage 3 trial will be on a larger group of people to gather data prior to seeking FDA approval.   For us week one started last Thursday.   Because Tuesday fits better in our lives he will move up a day at a time to make this change.   His next treatment will be at the start of week 4.   The first day June 13, will be the low dose chemo with the vaccine the next day.   

He is having some side effects.   The 6 doses of the vaccine are given just under the skin, 2 in the left upper arm, and 2 each on the top of each thigh.  After the injections were given each site was slightly red and swollen.   Saturday morning the places on his left arm were bright red and about 3 inches in diameter.   His legs didn't react as much but overall he felt like he was getting the flu, very tired and achy.   Now the question continues about why the legs have not reacted as fast as the arm.   In addition, why is his lower abdomen swollen and hurting?   There are more questions than answers.   

Another question we have been asked is about the blood draws.   The 4 small tubes were the normal draw before the chemo to make sure everything is okay.   According to the consent form the 16 large tubes will be taken again at week 4, 7, 10, 13, and 16.   The consent form said this was about 10 tablespoons, about 2/3 cup.   No wonder they are pushing him to drink lots of fluids.   These are all for research so we don't know exactly what they are looking at.   Before week 10 he will have the full set of CT scans and a EKG again.   All the labs, scans and drugs are paid for by the trial so there is no hassle or pre-approval needed.   I hope this answers some of the questions for you.   Please don't hesitate to ask, someone else is probably wondering too. 

Challenge

While Dave was having his challenges I was having fun with  the Brain Computer Interface.  If you are new to the blog check the May 7 entry.  Before my next session Betts had sent some suggestions of ways to direct brain waves so I thought I was ready to go.  Wrong.   Last time my scores were in the mid 60's.  Well this great new method gave me a score of 57.  Back to the original technique.  This only gave me a score of 71%.  Somehow I was going to beat that stupid computer.  I could have settled for 50 letters but stubborn me said no, I want the full 75. Of I went, but this time I blinked between letters at the very beginning and really emphasised the letter I was looking for.  It worked.  I was able to get to 81% ,just below the 85 needed to get to spelling words. With the score so close I was able to try a few words just to introduce the way it was presented.  At first I was completely unsuccessful but, once again, it worked better when I was very determined (some might say stubborn ) and really emphasised the letter.  Now I am gearing up for my next session

and continues

Once again Dave was facing an unknown experience.  Friday was vaccine day.   Carefully following the instructions, he shaved two areas on his thighs preparing for the ointment and tape.   He had to put a glob of skin numbing ointment the size of a fifty cent piece to prepare for the vaccine.   The printed instructions said to cover the ointment with plastic wrap and tape in place.   Much to caregiver Cindy and my disappointment the nurse gave him some clear center bandaids. 

As usual the nurse did the general health review and while the pharmacist thawed the vaccine, she reviewed the possible side effects and what he should do.   When the vaccine arrived in an ice chest with six syringes, each was inserted just under the skin in six spots.  The skin numbing ointment did the job, and the only thing he felt was the cold.   Since it was the first time he had to stay there for an hour to see if there was an allergic reaction.   Each of the six sites did show some redness so his body did respond as expected.   

This morning it really showed a reaction.   Along with the reaction he is experiencing some side effects.   It is not unexpected to have flu like symptoms and general fatigue.   Now we just have to see how long this lasts.   With 3 weeks until the next treatment there should be time for fun.   

it begins

Thursday morning is a mix of nervous anticipation, fear of the unknown and excitement about being part of a clinical trial.  Dave's first treatment started at 1:00.  First they reviewed all the consent forms. After he was settled in they turned into vampires collecting 16 large tubes and 4 small tubes of blood.  It took about 45 minutes to find  out if he was healthy enough to get the low dose chemotherapy infusion.  After that he received a 20 minute infusion of an antinausea drug.  Finally he started the low dose  chemo drug.   This process took about 30 minutes and gave him time to finish a movie he was watching on his computer.  Tomorrow begins at ten for the vaccine. Another  new experience

Frustrating Monday

Waking up to a grey, rainy day really set the stage for our mood.  Once again we were playing the waiting game and didn't like it any better.  Saturday had been busy and ended with a whole family dinner.  Sunday was Dave's sermon that had gone so well that there was a bit of a letdown on Monday morning.  Combine letdown, rain and waiting and the result is grouchy, stressed people. 



Fortunately I had an appointment for a wheelchair adjustment so we couldn't snap at each other   Finally mid-morning Laurie, the Clinical Trial nurse, called to say she had all the results but one, and he should qualify and be able to start on Tuesday.  The lab should have it by noon.  Noon came and went and so did 1:00.   At almost 2:00 Dave called Laurie but had to leave a message.  Finally Laurie called back but it was not with the expected information.  The lab had lost the test, could he go in and give another blood sample.  Arrrgh.  Good thing we only live 15 minutes away.  This also meant he could not start on Tuesday and had to wait until Thursday.



Friends bringing dinner helped with good conversation, wine and laughter.  Finally Tuesday afternoon we knew he was in but didn't know which section of the Clinical Trial.   With mixed feelings about the choice we waited again.   Once again I was lucky to have a distraction.   My second BCI (see post on May 7) needed full concentration.   Finally Wednesday morning he found out which group he is in.   Both groups start the same with low dose chemotherapy one day followed by a vaccine the next.  Similar to a TB test the vaccine is inserted just under the skin and creates blisters.  It is supposed to stimulate the immune system.  For him the third round will add a modified version of the bacteria listeria to give his immune system an added kick.  This cycle will be repeated for a total of four times, at which point the doctor will evaluate if the treatment is doing any good.   This is the time when all prayers, good thoughts and anything else will be helpful.

Question

What is the difference between these?  partly cloudy, some clouds, mostly cloudy, intermittent clouds, some sun, partly sunny, sun brakes

Reverend Greene

Today, Sunday the 20^th, was a special day for us.  Dave was given the opportunity to share a personal experience and story with our church.  He had shared the story with our minister, David, several weeks ago but had not thought seriously about sharing it with the congregation. As his diagnosis took shape, so did his desire to share.  He called David and left a message saying he wanted the opportunity to give the sermon on May 20th.  This was a first for the congregation.

Once he started Dave had everyone’s full attention.  I don't think I have heard it that quite for that long before.  Everybody laughed when they were supposed to and shed a few tears at times.  By the end most were moved by his message.  The Youth Director, who is a special Friend, had the burden or pleasure of giving the prayer after Dave spoke. She had a bit of a rough time that actually felt right.  David suggested we stand at the door to be there as people left.  Perfect ending and Dave had the opportunity to hug as many women as he wanted.  

Part above was written on Sunday, and I didn't share some of the many special moments.  First thing we saw a picture of our boat on the cover and inside of the bulletin.  Having both kids and their spouses share the day meant so much. Several friends came to hear Dave's first and probably last sermon. Additionally, members of the choir wanted to move to sit with the congregation to see and better hear Dave.  Total quiet broken by laughter showed that everyone was focused on his message.  Warm applause at the end was like a warm embrace. Arrangements were made to video the service, and we are looking forward to seeing and sharing it.  Several people have requested written copies, and Dave was happy to send what he written.  What he said might have been slightly different as he spoke from an outline.  It was wonderful to share his story.

Marathon Wednesday

After returning from a quick trip to talk with his Dad (that was a good visit) on Monday and Tuesday, Dave jumped completely into the cancer battle.   We started with an appointment with the palliative care team, then a CT scan followed by an EKG, then a bunch of blood tests and a urine test.  By the time he made it home he was exhausted.   

We had been a little surprised when we were scheduled for a meeting with palliative care because to us that is when hospice comes in.  Definitely not ready for that.   Instead of waiting until the end, they are now connecting with patients when a serious cancer diagnosis has been made.   With phone numbers and email along with personal interaction, the social worker and RN want to help guide us along the way.  Once again, we are fortunate to be part of a caring medical community.  (They will find it hard to match the ALS group) 

Laurie, the clinical research nurse, was waiting for Dave to give him the paper work for all the labs and whisk him off to start the CT scan.   Fortunately the stuff he had to drink didn't bother him. Laurie put a rush on an the labs, hoping to get everything in on Friday morning.   Three cheers for electronic transmission of information.   If everything came in Laurie hoped to have him randomised (Her word not mine) on Friday for a Tuesday start.  All treatments start on Tuesday or Thursday.  It did not work out. Friday Dave was called to to do some additional blood draws the lab had missed, and Laurie was out sick.  Dr, Crocenzi's nurse did the additional blood draws, and told Dave he probably qualified or they would not be asking for these tests.  We are hoping she knew more than she could say.  Now we wait for Monday.

Are you ready for this?

Next Sunday will be a different and interesting day at our church. Dave will be delivering the message. How did this come about you ask? Week before last when we got up Dave said he had been unable to sleep in the early morning hours because the same story kept running through his head. It surprised me that he was so calm about it. He said he would tell me later as I had to be ready for the first BCI session. Later that day our minister, David, came by and Dave shared with him. The more Dave thought about it the more he wanted to share the story. After we received the news about stage 4 cancer Dave went to talk with David and expressed his desire to share his story. After looking at the calendar Dave asked for the 20th. So if you feel the earth tremble at 10:00 on Sunday you will know why. Actually I feel he has a good message to share that could start good discussion.

Wednesday

I told Caregiver Yuki Wednesday morning that so many things were going through my head that I did not know where to begin. Don't expect this post to be organized. A good friend, Tony, called to see what we had learned on Tuesday. That started the process of letting people know what was going on. Trying to get our bearings, we each did our thing. Dave went to the Internet, and I drafted an email. It was hard to tell people so we went back to the way we communicated from the boat. I draft an email, and Dave cleans up my spelling and typos (even worse typing with my feet) and adds what he wants and sends it out.

Dave went to John Hopkins website and discovered more information about the clinical trial. The similar vaccine had been used successfully for post surgery patients, so now they had designed a trial for those not eligible for surgery, hoping to get the similar results. He then called the nurse in charge of the trial, Laurie, and asked more questions mostly about how the trial patients had been doing and what if it didn't work for him. She was going to a meeting with the local people working on the trial and would see if she could tell him anything. In order to get things started he needed to return the consent form. He told Laurie he would be there that afternoon.

After a short nap Dave went to talk with our minister, David. From there he went to meet with Laurie. She had talked with Dr. Crocenzi, the oncologist. (I will have to learn to spell his name, and Dave still struggles to say it). He told Laurie that he hoped Dave would choose the trial because he felt it was the best choice for us. Dave also had an opportunity to meet the social worker and find out about support groups.

Meanwhile we found out who gets email on their phone or happened to be on line at the time. We really appreciate the many thoughts and prayers sent our way. That evening friends from my Share the Care group were scheduled to bring us dinner, and we welcomed the company. In addition, other friends came when they read the email. The company was good. Dave shared what he had learned during the day to a very caring audience, and with people familiar with his sense of humor. During dinner the conversation ranged from sad to funny to philosophical and back again.

Once again we were thankful we had spent the time sailing. That topic brought up one of my favorite sayings from a sailing magazine. The difference between ordeal and adventure is attitude. Not sure how we apply than right now, but hope to add many small adventures. All your love and prayers are felt and appreciated.

NOOOOO

Many of you recived a version of this post by email  I am putting it in here in case I missed someone..If we did miss you I am very sorry.  Monday was a beautiful warm clear day that became dark when the surgeon called at noon.  The pathology reports indicated cancer on the panaceas and the liver.  The news was not unexpected but it still was hard.  On Tuesday our appointment with the oncologist was at 3:00.  The biggest news was that the cancer showing up in the liver meant the cancer was in the blood stream and therefore stage 4 and surgery was no longer an option.  The treatment options are bad, badder, and horrible.  Dave can also choose to do nothing and they would treat the symptoms.  There are two different standards of care, chemotherapy that is rough and survival rates are short and chemotherapy that is rougher and gives a few more months.  A third option is a clinical trial.  This trial has two different arms testing two different ways to stimulate the immune system.  Patients are randomly placed in each arm by the lead researcher at John Hoppins. Among the requirements are a CT scan to determine eligibility for the trial.  This would be necessary what ever choice he makes to establish baseline to see .if the treatment is working. All this is really difficult when they are talking about life expectancy in months.  Once treatment starts we have a schedule and be able to cram in as much living as possible.

My next adventure

One of the staff at the ALS association, Betts the communication specialist, left to take a new position at OHSU (Oregon Health Sciences University).  Her position is on a team developing a brain computer interface program to enable people to communicate when unable to move.  Betts asked if I would be interested in participating in the study.  It was a resounding yes.  Since I have been around too long to participate in any clinical trials, I am excited to maybe help make the future better this way. 

Betts first visit started with explaining the study and signing forms. We then proceeded to some preliminary tests to see if I had the ability to do the study. (I know Bill, as a good brother it is your job to say they were looking to see if I had a brain.)  One of the sections was a large picture frame where I was to indicate where a certain object was by looking at it. Another involved a series of letters going across the computer screen followed by a single letter. I was to indicate by a yes or no if that letter had been in the group. Yes, I did qualify for the study.

My first session was Friday and a welcome diversion from all the medical stuff going on with Dave.  Betts and her entourage showed up about 9 am.   Setting up all the equipment took some time.   Finding something to raise the computer high enough to be comfortable for my viewing took some thinking but Cindy found a basket that worked great.

Then Betts measured my head with a cloth tape measure, this time marking the mid-point each direction.   With a red X on my scalp marking the spot, she then put the cap on.  The cap has 18 electrodes that need to be in the correct section of the brain. After the cap is in place, a conducting gel is squeezed into each electrode to insure good contact.

Then the fun began. Each electrode shows as a line on the computer screen. They are looking for a regular pattern on all the lines. It is really fun to see what happens when I blink or look at a different person talking. We did all the trials and everything worked perfectly. Then on to the actual test, and my brain waves flat lined. (Yes Bill, I know what you would say.)  This was the reason the computer person was here.  She went to work checking all the connections and tried a different control box.   Finally found the problem and more gel was put in one connector on the cap and excess gel was wiped off 2 others. Then we could begin.

After a demonstration I began. A letter would show on the screen with the instruction to react with thought when the letter appeared again.  There were 75 series of letters that were shown in about 9 minutes.  Part of the instruction was to try not to blink when the letters were flashing but blink between sets. Rather interesting to try to control an unconscious movement.  I found the second set of 75 did not tire my eyes as much so I must have blinked more.   The last set I chose to do only 50.  My eyes were tired.  This was the first time the physical therapist had observed the process so he had a few questions.

It took a lot less time to pack everything then it took to set it all up. I didn't do that much but I was tired when they left about noon.  Still ahead was my shower and good hair wash to get the gel out of my hair.   I guess I could have left it and claimed it was styling gel.

One step down, how many more to go

Dave had an uneventful endoscopy. At this time he known several things. Using a light anaesthetic does away with the fuzzy head.  But having a tube down your throat and nose leaves a sore throat and runny nose. After the procedure the surgeon said he was able to get good samples and hopefully they provide good information.  While inside he did some sight seeing and found a spot on the liver that he also sampled.  As he looked around he also checked the tumor in relation to the artery.  It doesn't appear to be inside of the artery but is in an area full of veins and arteries. So now we wait again.  The surgeon did promise to call as soon as he knew something.  He called quickly last time so we feel comfortable that he  will again.             My quarterly ALS clinic was on Monday and our favourite lung doctor asked about Dave's doctors. He knows them all and feels they are very good.  One is also a personal friend.  We like him so much that we felt good about anyone he liked. Now we wait and see where the next path takes us.

today

Well today is the day for Dave's endoscopy. He is planning on telling the doctors not to stop until they get good tissue samples.  If they can't there are other procedures but that would involve more waiting.  We are so ready to have a plan . patience is virtue and we have never claimed to be vitreous.More important we are feeling blessed with so many praying for us.