Cancer Couple
We, David and Jana, were diagnosed with cancer within an 11 day period in 2010. What a surprise! I have mesothelioma, and Jana has chronic myelogenous leukemia, and this blog chronicles our experiences with these diseases. To get started, first take a look at the back stories on right below. Most posts are straight reporting of our experiences; however, a few are more analytic and philosophical (perhaps of more general interest) and can be found repeated in the Selected Posts list.
May 6, 2018
June 23, 2017
I Should Be Empty Now. . .*
A PleruX drain was installed in my abdomen on Wednesday and was a little more involved than just having a paracentesis. I had conscious sedation this time, and some pain since then, although that is getting better.
This afternoon Jana and I performed my first drain. They had drained about 1 L on
Wednesday, and we drained another liter today. Today's drain was done more to learn the procedure than to remove fluid, so I was surprised when we filled a liter vacuum bottle. We'll drain again in a couple of days to see if this first procedure was a fluke or whether I need to drain frequently. I had thought once a week might be enough.
David
PS When we returned home from having Afghan kabobs this evening, I noticed that my shirt was wet under my jacket. It turned out that my dressing was leaking fluid, so I called UC Hospital to talk with the Interventional Radiology fellow on call. He said that I probably had not drained enough fluid from my abdomen and to do the procedure again. I was skeptical, but we did the procedure. I was surprised to drain another liter of fluid which make 2,000 ml, the maximum for one day. It looks like I may be doing more draining than I expectd.
DD
*Sung to the tune of "I Can See Clearly Now."
This afternoon Jana and I performed my first drain. They had drained about 1 L on
Wednesday, and we drained another liter today. Today's drain was done more to learn the procedure than to remove fluid, so I was surprised when we filled a liter vacuum bottle. We'll drain again in a couple of days to see if this first procedure was a fluke or whether I need to drain frequently. I had thought once a week might be enough.
David
PS When we returned home from having Afghan kabobs this evening, I noticed that my shirt was wet under my jacket. It turned out that my dressing was leaking fluid, so I called UC Hospital to talk with the Interventional Radiology fellow on call. He said that I probably had not drained enough fluid from my abdomen and to do the procedure again. I was skeptical, but we did the procedure. I was surprised to drain another liter of fluid which make 2,000 ml, the maximum for one day. It looks like I may be doing more draining than I expectd.
DD
*Sung to the tune of "I Can See Clearly Now."
June 20, 2017
The Symptoms of Dying
Here's a great article for those of us who are getting older and our families and friends--The Symptoms of Dying.
https://www.nytimes.com/2017/06/20/well/live/the-symptoms-of-dying.html?hpw&rref=health&action=click&pgtype=Homepage&module=well-region®ion=bottom-well&WT.nav=bottom-well
https://www.nytimes.com/2017/06/20/well/live/the-symptoms-of-dying.html?hpw&rref=health&action=click&pgtype=Homepage&module=well-region®ion=bottom-well&WT.nav=bottom-well
June 10, 2017
A Two-Part Update
"Draining the Swamp"--The Sequel
On Tuesday I went in for another draining of the fluid in my belly. This time they removed 3.6-3.8 liters of fluid. Knowing when to request draining is difficult because the fluid collects slowly, so there is no big change in my symptoms from day to day. However, I was so uncomfortable last week that I requested the procedure, and my oncologist's office arranged for me to have it on Tuesday.
While waiting to go to the operating room I asked the nurse about a permanent drain that I could use to empty the fluid on my own at home. She brought in a DVD about the PluerX system that Jana and I watched. Yesterday, I asked my oncologist to put in an order for the installation procedure which will be performed on 21 June.
The procedure involves the insertion of a drainage tube into my abdomen. The tube remains in place, and the end sticking out of the side is covered between use by a bandage. When the time comes for another drain (perhaps once a week), I will attach a vacuum bottle to the tubing and suck out the fluid. I should be much more comfortable. For the curious, the first two minutes of the video on this page shows how it is used: http://www.bd.com/en-us/offerings/capabilities/interventional-specialties/drainage/about-the-pleurx-drainage-system/patient-information-pleurx-system/how-to-drain-at-home
Late Tuesday afternoon I had a CT scan in preparation for my visit with my oncologist on Wednesday.
The End of Cancer Treatments
My CT showed that my tumors were not stopped by the three infusions of Avastin that I had over the past nine weeks. Consequently, we've run out of treatment options. My oncologist would probably prescribe another chemo, but I see no reason to go through chemo again when I don't think it would do any good against mesothelioma. There are probably one or two meso-specific treatments in development, and if they are approved by the FDA in time, I'll give them a try.
We had a talk about end-of-life decisions, and he gave me a copy of Five Wishes, a living will that provides a plain-language approach to those decisions (https://www.agingwithdignity.org/five-wishes/about-five-wishes). He said it is hard to make a prognosis because people often go downhill slowly and then quickly drop off a cliff. One can look at the trajectory of decline, but it's not very useful. He thinks I have less than six months left. I'll have a CT in eight weeks so I can see how things are progressing--a check of trajectory.
I don't want my readers to be saddened by this news. We all knew it's been inevitable that this day would come (for all of us). It's kind of a relief to know that there are no more treatment options. It's time to research hospice options in Denver and to get the most out of my remaining days.
PS I learned this week that John Shively, a colleague for two years in the DoDDS-Pacific Director's Office, died from mesothelioma. We got back in touch a couple of years ago when I learned he had mesothelioma, and it was good to compare notes. I thought he was holding his own against the cancer, but I was wrong. Posts on his Facebook page testify to the affection and high regard colleagues and students had for him.
On Tuesday I went in for another draining of the fluid in my belly. This time they removed 3.6-3.8 liters of fluid. Knowing when to request draining is difficult because the fluid collects slowly, so there is no big change in my symptoms from day to day. However, I was so uncomfortable last week that I requested the procedure, and my oncologist's office arranged for me to have it on Tuesday.
While waiting to go to the operating room I asked the nurse about a permanent drain that I could use to empty the fluid on my own at home. She brought in a DVD about the PluerX system that Jana and I watched. Yesterday, I asked my oncologist to put in an order for the installation procedure which will be performed on 21 June.
The procedure involves the insertion of a drainage tube into my abdomen. The tube remains in place, and the end sticking out of the side is covered between use by a bandage. When the time comes for another drain (perhaps once a week), I will attach a vacuum bottle to the tubing and suck out the fluid. I should be much more comfortable. For the curious, the first two minutes of the video on this page shows how it is used: http://www.bd.com/en-us/offerings/capabilities/interventional-specialties/drainage/about-the-pleurx-drainage-system/patient-information-pleurx-system/how-to-drain-at-home
Late Tuesday afternoon I had a CT scan in preparation for my visit with my oncologist on Wednesday.
The End of Cancer Treatments
My CT showed that my tumors were not stopped by the three infusions of Avastin that I had over the past nine weeks. Consequently, we've run out of treatment options. My oncologist would probably prescribe another chemo, but I see no reason to go through chemo again when I don't think it would do any good against mesothelioma. There are probably one or two meso-specific treatments in development, and if they are approved by the FDA in time, I'll give them a try.
We had a talk about end-of-life decisions, and he gave me a copy of Five Wishes, a living will that provides a plain-language approach to those decisions (https://www.agingwithdignity.org/five-wishes/about-five-wishes). He said it is hard to make a prognosis because people often go downhill slowly and then quickly drop off a cliff. One can look at the trajectory of decline, but it's not very useful. He thinks I have less than six months left. I'll have a CT in eight weeks so I can see how things are progressing--a check of trajectory.
I don't want my readers to be saddened by this news. We all knew it's been inevitable that this day would come (for all of us). It's kind of a relief to know that there are no more treatment options. It's time to research hospice options in Denver and to get the most out of my remaining days.
PS I learned this week that John Shively, a colleague for two years in the DoDDS-Pacific Director's Office, died from mesothelioma. We got back in touch a couple of years ago when I learned he had mesothelioma, and it was good to compare notes. I thought he was holding his own against the cancer, but I was wrong. Posts on his Facebook page testify to the affection and high regard colleagues and students had for him.
April 18, 2017
An Interesting, if Unexpected, Day at the Hospital
I thought that this was going to be an
unusual week in which I did not have an appointment at the University
of Colorado Hospital. I was wrong.
I noted in my last post that fluid was
collecting in my abdomen. That continued and caused several
unpleasant problems, so last night I sent a message to my oncologists
office asking what I needed to be evaluated for a paracentesis—a
procedure to drain the fluid from my abdominal cavity. This morning
I received a call from the nurse at my oncologist's office asking if
I could come in for labs and a visit with the oncology nurse
practitioner (NP) and a paracentesis later in the day. Jana and I
rushed around and headed to the hospital. I had my port accessed and
my labs drawn. Then I saw the NP and went over to IR.
The procedure was interesting. After
talking to the radiologist and signing the relevant papers, they
wheeled me into the procedure room—a very impressive room with all
kinds of equipment. First, the radiologist came in and used
ultrasound to determine where the fluid was pooling. I was happy to
learn that for this procedure, I would have no anesthesia. I would
be awake and could observe what was happening. After deciding where
he would install the drain, the nurses prepped me and covered me from
head to toe with a sterile drape. Then the doctor returned and
performed the procedure.
First, he injected a local numbing
agent which stung and was the only pain associated with the
paracentesis. He then inserted a needle into my side passing through
the skin, muscle, and the abdominal wall using ultrasound as his
guide to where the needle was going. As I understand it, once the
needle was in place he pushed in a rubber tube that went around the
needle and then withdrew the needle. Using a syringe, he withdrew
three specimens of about 100 ml each. Then he attached a pump the
the tubing and started “draining the swamp.”
Now an interesting procedure became
boring. The doctor took a phone call and went out for a while. The
nurses hung around doing something at computer screens and watching
over the fluid flow into the receptacle. I just laid there with
nothing to do. I looked around the room trying to figure out what
all of the equipment was used for (with little insight). I was lying
on my back with the tubing running from the insertion point on my
side, over my right shoulder, and to the pump. If I turned my head
to the right I could watch the flow in the tubing. There were
bubbles in the fluid which allowed me to see the speed of the flow.
So I watched that for a while and saw how the flow stopped and
reversed when one container was filled and was replaced. Not very
exciting.
They removed about four liters of fluid
from my abdomen. When I got home I compared my weight then with my
weight when I got up this morning. I lost 9.2 pounds. Before the
procedure, if I lay on my back and moved my hands down my skin across
my ribs, my abdomen would bulge upward at the end of the ribs like a
pregnant woman. Afterwards, my hand fell off of a cliff when the got
to the ends of the ribs.
My assumption has been that the fluid
collecting in my abdomen was caused by my cancer just as the pleural
effusion I had seven years ago led to the discovery of my
mesothelioma. It may be that the abdominal mesothelioma is not the
only cause. The doctor said that the load of disease in my right
pleural area may be impeding the flow of lymph causing it to pool in
the abdomen. As I understand it, as blood passes through the body,
blood plasma passes through the vessel wall in order to take
nutrients, immune cells, etc. to the tissues. This fluid then passes
back through the lymphatic system to be dumped back into the blood
near the heart. The flow goes up from the legs towards the heart;
however, my tumor burden may be impeding the flow causing the fluid
to back up in the abdomen. He said there are ways of controlling the
flow, and he would talk with my oncologist about this potential
complication.
After he put on a dressing, I was
wheeled back to the nursing area where they gave me some cranberry
juice and made me wait 30 minutes before I was released.
All in all it was an interesting trip
to the hospital. The good people in my oncologists office were
champs, going all out to arrange for the paracentesis on a short
schedule. Luckily there was an opening in IR that they could take
advantage of. And, of course, Jana was a champ as usual for getting
me there, waiting through the procedure, and bringing me home.
David
April 2, 2017
The Beginning of the End
Since my last entry I have been in a
holding pattern with regards to my mesothelioma. In the interim, I
had cataract surgery on my right eye which went very well. It was
pain free and except for my astigmatism, I now have clear distance
vision for the first time since I was in the third grade. The thing
that impressed me the most was how much brighter and more colorful
the world appears now through my right eye. i had no idea I was
looking through a yellow-brown haze. I gather that this is a common
revelation to others who've had the surgery. I'll have my other eye
done on Thursday.
Back to mesothelioma. On Monday I
had my first CT since January, and on Wednesday we saw my oncologist
for the results. They were not good. My mesothelioma has
grown through the diaphragm into my abdomen.
The abdomen is lined with the same
kind of tissue as the chest cavity, so the cancer seem very happy to
be in the abdomen and is flourishing. It is forming a crust across
the top of my liver and down the sides. However, the lungs seem
pretty stable. Dr. Camidge offered a new chemotherapy and a
monoclonal antibody that works against the formation of new blood
vessels (thereby starving the cancer). I asked the prognosis if
I did not do anything, and he said probably less than a year. I
told him that I didn't have much faith in the chemo helping, and I
didn't want to spend the time I have left under the effects of both
the chemo and the cancer. He understood, and we agreed to give
the antibody (minus the chemo) a six week trial and regroup then.
The monoclonal antibody is called
Avastin (bevaciizumab). Monoclonal antibody drugs (generic name ends
in ..mab) are man-made antibodies that work through the immune
system. Avastin is a member of the class of drugs that are designed
to combat angiogenesis, the creation of new blood vessels. The idea
is that the cancer needs new blood vessel to grow, and if the drug
prevents the creation of the blood vessels, the cancer will stop
growing. Avastin is not as effective as some of the newer immuno
drugs, and as my doctor recommended is usually given with a
chemotherapy agent, so I don't expect much, if any, improvement;
however, I'll give it a try. I get my first infusion on Wednesday
and then again three week later, assuming that insurance will pay for
it. Avastin is not licensed for mesothelioma.
It looks like I'm entering the
beginning of the end, and it's time to get my affairs in order. When
I was first diagnosed seven years ago, I thought I had six months to
live. I realized intellectually that I had an incurable disease, but
it never seemed real or my death imminent. After a couple of years
when my cancer showed itself to be rather indolent, I realized that I
had a longer life expectancy than that. Now it seems clear that my
time is getting short, and for the first time i feel my mortality
emotionally, a feeling that meso going to take my life.
PS. I knew something had changed
because my belly looks like it's inflated. Even our five-year-old
granddaughter noticed and remarked on it. When examining me, my
doctor said I look like I'm pregnant. He quickly said that I was one
of only a few patient that he could say that to. I appreciated the
fact that we have gotten to know one another well enough for him to
understand that I would not be offended.
David
February 11, 2017
Out of the Clinical Trial and into a Holding Pattern
As of Tuesday, I am no longer
participating in the clinical trial. Given that the last CT showed
no evidence of effectiveness, and after the supraventricular
tachycardia and the pericardial effusion, my oncologist decided that
the risk of serious side effects was too great. I was ready for
three more weeks, but he wouldn't agree to it. Of course, I am
disappointed, but I have to admit that I am relieved and feel
somewhat better—more energy. Do I feel better because the end of
the trial created a placebo effect, or do I really feel better? Who
knows? We'll have to see what happens. The plan is to do nothing
for sixty days, and then have a CT to assess my status at that time
and see what the next move should be.
The next day I had a very good
appointment with my cardiologist. I'm also in a wait-and-see
position with my heart. I'll have periodic echocardiograms to see if
the pericardial effusion (fluid build up in the sack around the
heart) comes back. If it does, I'll see a cardiovascular surgeon to
determine whether I need a pericardial window. That is an operation
in which they cut a hole in the pericardium to let the effusion drain
into the chest cavity. It is not a minor surgery, so if I need it,
the question is whether I am up to the surgery.
Yesterday I got a pathology report on
the fluid drained from the pericardium. Combined with the previous
reports we know that the fluid contained no aerobic or anaerobic
bacteria, no malignant cells, but did contain a few mesothelial
cells. The leading hypothesis is that the effusion was caused by
mesothelioma in my pericardium. The pleural effusion that I was
having at this time seven years ago was caused by my then-undiagnosed
mesothelioma, so it doesn't seem like much of a stretch to believe
that the recent effusion is also caused by mesothelioma, but this
time in my pericardium.
David
January 29, 2017
Clinical Trial Update, Emergency Room Visits and Hospitalization
Clinical
Trial:
I'm now in the 14th
week of my clinical trial. Last week I had a CT scan that showed
that the two immunological drugs do not seem to be reducing my
tumors. It appears that my tumors have increased in size by about
10%. If they increase by 20% I will not be able to stay in the
study. My oncologist and the oncology fellow who was with him didn't
come out and encourage me to stop the trial, but they seemed to favor
quitting and going back to chemotherapy. I had read that sometime
the tumors seem to increase in size before shrinking. They did not
think that was the case because in only happens rarely. After
discussion, I decided to stay in the trial for two more cycles when
I'll have a CT, and we will see if the drugs have failed.
I
am not excited to try a new chemotherapy. I'm not sure I can
psychologically or physically take another chemo drug. My treatments
have extended my life far beyond what is normal in mesothelioma, but
they also take a toll on the body and mind. My oncologist said there
is no way to know, but I might live one or two years if I stopped
treatments entirely. Of course, my health would deteriorate during
those months.
Emergency
Room Visits and Hospital Stay:
On Tuesday evening (Jan 24th)
while watching a movie, I noticed that I was feeling funny and
checked my oxygen level and heart rate. My heart was beating in the
mid-130's while just sitting on the couch. When the movie was over,
I called the Phase I Trial Clinic oncologist on call and was told to
go to the emergency room. They diagnosed me as suffering from
supraventricular tachycardia (SVT), a condition in which the signal
to start a heart beat comes from an abnormal location in the heart.
The result is a rapid heart (tachycardia) rate and an abnormal ECG
wave form. To correct the problem,you might say they had to punch my
heart's reset button by stopping my heart and bringing back the
normal rhythm. The procedure has the possible side effect of
stopping the heart completely, so they attached pads from a
defibrillator on my chest and back in case my heart did not restart
and the shock were needed. I was not thrilled at the prospect of
having my heart restarted by a defibrillator. To stop the heart they
gave me a dose of adenosine, a substance that is normally in the
body, but not in large concentrations.
It
was a little like medical theater because of the size of the group of
people gathered around to watch. In addition to the doctor and nurse
doing the procedure, there were several others who may have been
medical students or residents. The doctor told me that there would
be some discomfort as my heart slowed down and stopped. Some people
describe it as being kicked the the chest. The setup was such that I
could hear my heart beat through a speaker. A couple of seconds
after the injection of the adenosine, I could hear my heart rate
decrease. As it neared the bottom, I was very short of breath and
had to breath quickly. It was unpleasant but not like being kicked
in the chest. Perhaps it was like having your breath knocked out.
Then for a fraction of second there was no beat, but it returned and
sped up in a normal non-tachycardial rhythm. There were smiles all
around. The doctor asked if I'd noticed their concern as the heart
rate dropped. I apparently hovered around 30 bpm for a few seconds
before stopping. I hadn't noticed because I was focusing on getting
a good breath. We then had to wait around for a while to make sure
things were going well, and they cut us loose. No one wants to go
through something like this, but I found the experience to be very
interesting. I had no idea that doctors had such a method of
resetting the heart rhythm.
On
Thursday, I ended up back in the ER. In response to the tachycardia,
the Phase I Clinical Trial Clinic scheduled an echocardiogram for
early Thursday morning. I also had two other appointments scheduled
for that morning. First I was to have my eyes measured for cataract
surgery, and then a meeting with a nurse practitioner in the Phase I
Clinic to go over ultrasound results. While in the waiting room for
the cataract measurement, I got a call from the nurse practitioner
telling me to hie myself to the ER because of a pericardial
effusion—fluid in the sack surrounding my heart (pericardium) was
putting pressure on my heart and needed to drained.
The
doctors in the ER did another bedside electrocardiogram to verify the
extent of the effusion, and scheduled me to have a pericardiocentesis
which involves inserting a tube into the pericardium and draining the
fluid. They drained about 10 ounces of fluid, and admitted me to the
hospital for observation. The next day, I had another
echocardiogram, they removed the tube, and I was released.
The
cause of the pericardial effusion is unknown. The extracted fluid
has been sent off for analysis, and it is likely that the effusion
was caused by my mesothelioma. If that is the case and it returns,
they would likely go back in and cut out a piece of the pericardium
to create a drain hole to let the fluid out into the chest cavity.
All
in all, it was not an uplifting week, but it was interesting. I am
going to put off my cataract surgery until I've seen my cardiologist,
and see if I will be removed from the clinical trial. I need the
surgery, but I have too much on my plate to have it now.
David
David
December 9, 2016
Clinical Trial Update--End of Cycle 2
It's been six weeks since I began my
clinical trial which is organized in three-week cycles. On the first
day I received an infusion of what we can call my PD-L1 drug. Then
on the first day of cycle two, I got another infusion of the PD-L1
drug and started taking the other drug that we can call the IDO drug.
During cycle 2 I took 12 capsules of the drug (50 mg/capsule) twice
a day for a total of 504 capsules in cycle 2. On Tuesday cycle 3
began, and they changed my IDO dose to 3 tablet of the drug (200 mg
each) twice a day. I joked that I feared I'd get gelatin poisoning
from taking that many capsules during cycle 1.
About halfway through cycle 2, I
developed a light, widespread rash over my stomach, back and legs.
It was not itchy or raised, just there. On day 15, the nurse
practitioner examined the rash and put me on 10 mg/day of prednisone, a
steroid. She apparently told me to discontinue the IDO drug, but
misunderstood and continued to take it. At an exam three days later,
the rash was improved, so she said
to continue with the drug and the prednisone. Then on Tuesday (first
day of cycle 3), my oncologist looked at the rash and said I could
stop the prednisone. The rash was evaluated as a grade 3 event (on a 1-5) scale, which would make it count as a serious event; however, it had not effect on my well being.
In the
time between the Friday visit with the nurse practitioner and the
Tuesday visit with my oncologist, I read what could be taken as a
frightening article in the New Your Times. The reporter highlighted
the fact that getting two immuno therapies at the same time has been
associated with unusual, life-threatening adverse effects.
I had
already seen references to this problem, but the profiles of two
patients who had bad effects made the concern concrete. It appears
that the female patient in the article is participating in the same
trial I'm in, but at Yale. I looked at abstracts of the cited articles and verified the reported statistics; however,
the reporter did not mention that the journal articles concluded that
the adverse events were controllable.
What I
took away from the article was that the communication between the
doctors treating the adverse events and the study docs was not
optimal, so I created a card to carry in my wallet with instructions
(in case I were unconscious from an accident) and was being
taken to an ER by EMS.
I
noted that I am participating in clinical trial that can produce
unusual side effect, that I should be taken to the University of
Colorado Hospital ER, if possible, and I provided phone numbers for
the clinical trial doctors, so the ER could get in touch with them quickly. These events are rare, and I am confident
that they can be managed with prompt, accurate medical care. The
bottom line is that the potential benefit far outweighs the risk.
On
Monday, the last day of cycle 2, I had a CT scan and received the
results on Tuesday from my oncologist. I was a little hopeful that
they would be positive, because even though my fatigue and weakness
seems to fluctuate across days, it seems that my coughing and
breathing have improved. Unfortunately, the results showed no clear
improvement but no decline either, so I will continue with the trial
and have another CT in six weeks.
November 21, 2016
About Clinical Trials and My Experience so Far
This
is a long post about clinical trials and my experience so far. Not for everyone.
What
is a clinical trial? A clinical trial is a research study done
after previous research (typically in animals) has shown that a new compound or
treatment may be beneficial to patients.
Trials are typically funded and managed by the company or institution
that created the treatment; however, in some cases the government will fund a
study through, for example, the National Institute of Health (NIH). The NIH describes clinical trials this way:
· Phase I: Researchers test a new
drug or treatment in a small group of people for the first time to evaluate its
safety, determine a safe dosage range, and identify side effects.
· Phase II: The drug or treatment
is given to a larger group of people to see if it is effective and to further
evaluate its safety.
· Phase III: The drug or treatment
is given to large groups of people to confirm its effectiveness, monitor side
effects, compare it to commonly used treatments, and collect information that
will allow the drug or treatment to be used safely.
·
Phase IV: Studies are done after
the drug or treatment has been marketed to gather information on the drug's
effect in various populations and any side effects associated with long-term
use.
I
think a Phase I trial may be the most dangerous and unpleasant of the trials
because before the trial, the researchers do not really know how people will
respond to the treatment. Part of the
trial is a dose escalation phase in which the maximum tolerable dose is
determined. Patients are given
increasingly stronger doses until they develop serious side effects or quit the
trial because of the side effects. My
clinical trial is an expansion of Phase I.
The drug GDC-0919 has been given to a small number of patients and the
effects of different dose levels have been examined. The expansion adds additional patients with
different cancers and different characteristics. I think it may be unusual, but my trial is
being conducted at 11 sites in the US and is being set up in three sites each
in France, Korea, and Spain. It suggests
to me that they think they are on to something good with GDC-0919.
A
Phase I trial also provides some evidence of effectiveness; however, more patients
with perhaps different diseases are needed to get sufficient evidence of
success, the Phase II trial.
The
Phase III trial is where the rubber meets the road. In this phase, the new treatment is compared
with a previously approved drug or treatment to measure effectiveness and
safety. I think Phase III trials are
often done in multiple locations in order to get more and a better variety of
patients. If the Phase III trial shows
that the treatment is effective, the sponsor determines whether or not to seek
approval from the Food and Drug Administration (in the US).
How does one find
clinical trials? A clinical trial may be suggested by your
doctor, or you can go online and search for them. The best source of trials can be found on the
NIH website: https://clinicaltrials.gov/. You can search by disease and trial
location. If you look at the entry for
my trial (https://clinicaltrials.gov/ct2/show/NCT02471846?term=gdc-0919&rank=1) you will see:
· the purposes of the study,
· a description of the various arms (groups of patients) of the study,
· the requirements for participation in the study,
· the conditions for elimination for the study, and
· information about where the study is being conducted.
If
you live near a NCI designated Comprehensive Cancer
Center,
you can probably find a list of locally available trials on their web site.
How to join a trial. When I applied for a clinical trial run by
the NCI last January, I think I applied before talking to my oncologist about
it; however, I think it would be a good idea to talk to your doctor first. You first contact the study coordinator and
complete their paperwork. I had to have
the hospital send certain medical records to the NCI. For the trial here in Denver the hospital
already had the medical records on hand.
The
medical records are used to determine if you are sick enough but not too sick
to participate in the trial. They look
at the list of inclusion criteria to ensure that you are sick enough. For example, in my case, I had to have solid
tumors, and they had to show “Progression following at
least one standard therapy; or standard therapy considered ineffective,
intolerable, or inappropriate; or use of an investigational agent recognized as
a standard of care.” The idea being that
they do not want to use an experimental drug that might be unsuccessful when an
already approved standard treatment is available.
They
also want to make sure that participants do not have other conditions that
might keep them from completing the trial.
The NCI rejected my application because I use supplemental oxygen; i.e.
I was too sick to participate. I asked
my oncologist to let them know that I lived in mile-high Denver and had not
used oxygen the summer before when traveling from Denver to Michigan and back. Bethesda, MD is near sea level, so I would be
OK. They accepted his argument, and I
was accepted; however, congestive heart failure arose, and I withdrew from the
trial.
The prescreening. For my trial, I had to have a prescreening
visit in which I was weighed, measured, and poked. I also had to have a tumor biopsy because my
tumor cells had to display the PD-L1 protein.
That involved inserting a coring needle through my back into my tumor
and extracting a piece of the tumor. The
procedure was done as a day-surgery, and I was given some anesthesia during the
process. Of course, you have to go
through a consent form with the provider to ensure that you know what will be
happening and what the risks are. My consent
form was eight pages long, but it was clear and the nurse practitioner made
sure we talked about all aspects of the form.
Starting the Trial. A week before my first treatment, I had
another exam, many tubes of blood drawn, and a CT of my lungs. Genentec, the company sponsoring the trial,
covers the bases thoroughly. Eighteen
blood tests were run on the blood drawn that day. The consent form was 37 pages long, but the
nurse practitioner went over it page by page to make sure everything was
clear. To participate, you basically
give your body to them. I agreed . . .
· that I would receive no compensation for participation,
· that they can take the tissue as described in the consent form,
· that they can keep what is in excess for other research purposes, and
· that I understood that the risks of the treatment are not fully
understood because it is experimental.
They
agreed . . .
· that I can withdraw from the program at any time,
· that they will bear the costs of the study including treatment for harm
done by the treatment,
· that I am responsible for any costs that would be part of my regular
medical treatment, and
· that they will protect my privacy.
The study is run in three-week cycles, and the consent form went through what would be done in each cycle—blood draws, infusions, CTs, biopsies, etc.
For Genentec this is more than a study of how
effective these two drugs, Tecentriq and GDC-0919, are when given together and
how they might interact. The tissue and
blood samples will contribute to their ongoing research about how cancer forms
and spreads. They may sequence my entire
genome for their research purposes, and neither I nor my doctor will have
access to the results. They may make
tons of money from the combined data of the participants. I’m OK with that because my cells and
molecules might contribute to the advancement of science and medicine. I’m happy to contribute in honor of the
clinical trial participants who paid it forward in getting us to the state we
are in now with cancer treatment.
One
week later, October 27, when all that information had be examined, I went to
the hospital for my first treatment.
More routine blood draws and a urinalysis were performed, and when the
results didn’t find any problems, I went down to the infusion center to get my
first dose of Tecentriq. The infusion
took 30 minutes, and I had to wait under observation for 30 more minutes with a
blood draw before the infusion and after the observation period. Nothing happened to be observed.
Blood
is taken at different times in a trial cycle for three purposes. General blood tests and a urinalysis are
taken before any office visit to see if my general health is strong enough to
continue. At an infusion of Tecentriq or
the initiation of a new round of GDC-0910, they take pharmacokinetic blood
samples to see how long the drug remains in my body and pharmacodynamic (PD) samples
to see how the body processes the drug at the same time.
I had a long day at the hospital when I returned
almost three weeks later for a Tecentriq infusion and my first dose of
GDC-0919. I had a blood draw at 7:10 am,
a visit with my oncologist at 8:15 am, and then went down to the infusion
center. I finally left the hospital
about 5:45 pm. They took blood before
and after my infusion. After taking my
first dose of GDC-0919 they took blood at 15 minutes, 30 minutes, 1, 2, 4, 6,
and 8 hours after dosing. About a cup of
blood is taken in total on these long days.
When I go back tomorrow for the start of my second cycle of the oral
drug, I’ll have another long day, but that is the last one. After that the blood draws will only be taken
before treatment.
I have a port implanted under the skin of my chest
which is connected by a tube to a large blood vessel, the superior vena
cava. It is accessed (virtually
painlessly) when I go the lab at the start of a day. I am left accessed which means that a sort of
pigtail of tubing comes from the port needle and is used throughout the day to
take blood. The needle is removed at the
end of the day (painlessly). I love my
port; however, when I get an infusion they cannot draw blood from the port
because of concern that all the drug would not be flushed out and would
contaminate the blood draw. On those
days, I get an IV for the infusion, and all of the blood draws are taken from
the port.
So what do I do on those long days? Once they get through the first few blood
draws, I am moved from the infusion chair to a room with recliners where
subsequent blood draws are taken. I can
leave and go downstairs to eat, walk around, etc. as long as I am back in the
room for my next scheduled blood draw.
Last week I read a book, a magazine, and the news on the internet and
played Spider Solitaire. By the way, the
people in the infusion center are great—friendly, helpful, smart,
knowledgeable, efficient, and on top of things.
I am always inspired by the competence of the people at the University
of Colorado Hospital.
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