A First Person Account - Jack
Beaven's experience with Provenge
Prior to being accepted for the
trial, Jack writes:
For the trial, 2/3 of the participants receive the vaccine and 1/3 get a
placebo. If anyone progresses on the placebo, he is given the option
of participating in a follow-up trial in which he receives the vaccine.
[Dendritic cells have been frozen and saved for this potentiality.]
This "2nd chance" provision was a major reason I was willing to
participate. Also, no matter how my numbers & tests have fluctuated
over the years, I'm still feeling physically fine -- "If I didn't KNOW I
had this disease, I WOULDN'T know I had it." [Also why I've been
willing to try some "off-the-wall" therapies.] See below.
Now, we all know that
NOTHING works for EVERYONE. So, whether this will help me or not, I
don’t know—but I think it’s worth a shot.
After a failed radical
prostatectomy in 1992, resulting in a metastasis on my left scapula, CHT
worked for me for about 3-1/2 years. PSA nadir was 0.2, from which
it started to rise.
At PSA 34.1, I started
2nd line hormonal treatments with Cytadren and Hydrocortisone,
which worked for another 3 years or so. Nadir was 5.3.
Since then I have
tried Rife/Bare, PC SPES, Carnivora, GCP, and GCP with AHCC. None of
them stemmed the rising tide of PSA, which currently is 34.5.
However, my QOL is
quite good. The met gives me no pain or discomfort, and bone scans
have shown it to be “stable” for the past 4 years. I tell people
that if I didn’t KNOW I had this disease, I WOULDN’T know I had it.
I attribute at least some of this situation from radical diet change and
addition of beneficial supplements, etc. that we all know about.
But, I do know I do.
And because it’s like the proverbial sword of Damocles over my head, I am
hoping to be accepted for the Provenge trial.
I do believe that a
cure (or permanent control, which to my mind is just as good), whether from vaccines, anti-angiogenesis, gene therapy, or
whatever is in the offing, and I plan to stick around until answers are
found.
My tea tag this
afternoon says: “Not everything that is faced can be changed, but
nothing can be changed unless it is faced.”
Here’s How Things Went
as I Explored Entering the Provenge trial and events after acceptance and
entry into the Provenge trial:
Eligibility:
1. Prostate cancer
that has spread outside the prostate gland
2. Disease progression
despite treatment with hormone therapy
3. No cancer-related
pain
4. A rising PSA
After preliminary
interview at a local site, data is submitted to Dendreon. Prior to
this interview, I provided my PCa history, copies of the pathology
reports from the biopsy and from the surgery, and copies of my last 2
PSA reports. At the end of this interview with the Clinical
Research Coordinator, she expressed the opinion that I am an excellent
candidate. If I’m accepted, we’re aiming at a January-February
2002 time frame for the procedures.
The Clinical Research
Coordinator is in contact
with the hospital where I had the RRP to obtain pathology slides, etc.
To determine final
acceptance, I will have a physical exam, blood tests, urinalysis, an
EKG, a chest X-ray, a bone scan, and a CT scan or MRI. If you are
accepted, you are randomized to receive the treatment (2 of 3) or a
placebo. If my condition worsens on the placebo, I will be offered
the opportunity to enter a follow-up trial with the active vaccine.
The coordinator
told me that we probably will not know the final decision until about a
week or so before the start of the procedure.
Here's how things looked before and during the procedure(s).
1. Provide PCD, last few PSA reports, recent scans, pathology reports from
surgery, permission for them to borrow films, etc .
2. When still
eligible, submit to baseline tests: Bone Scan, CT Scan, blood tests, Chest
X-Ray, EKG. These were done at Riverside Memorial Hospital in
Columbus (the only Ohio site for the trial) on 12/27 &12/28/01.
Following this, and providing a couple of other clarifications, I was
accepted for the trial.
3. Blood cells will be
removed from me by leukapheresis—the blood flows from a vein in one arm to
a machine where immature dendritic cells and mononuclear cells are removed and
saved, and the rest of the blood flows back into a vein in my other arm.
On 1/8/02 I went in for the leukapharesis
procedure. You lie still & can't move your arms during the process, which
in my case lasted about 2-1/2 hours. It really wasn't too bad.
My wife was at bedside & able to feed cassettes into a portable player so
I could listen to jazz during the time, I could talk to her, and also the
ones performing the procedure.
4. The dendritic cells
are then treated with a prostate tumor protein for 40 hours to produce the
vaccine. (If I’m in the placebo group, dendritic cells will be
frozen and saved for possible future use.)
They Fed Ex the
product to a processing center -- in my case I believe it was in
Philadelphia -- where the vaccine is prepared over a period of 40 hours.
On 1/10/02 I returned to Columbus in the afternoon, and when the
vaccine (or placebo) arrived, it was infused back into me. This
takes about a half hour.
On Monday afternoon
(1/13) I returned to Columbus for an appointment with the Doc conducting
the trial and blood tests.
5. The same procedures (physical exam, blood tests, leukapheresis, and
infusion) will be repeated two weeks and four weeks after the first
treatment. That ends the treatment cycle.
This same series was repeated on 1/22, 24, & 27 and 2/5, & 2/7.
The therapy portion of the trial was complete at this point -- Dendreon
feels that 3 cycles is optimum to "train" the dendritic & T-cells, and
that they will survive and remember permanently.
5. Physical exams and blood tests to monitor condition and look for treatment
complications will be repeated at weeks 8, 12, 16, 24, 32, and the every
12 weeks after starting treatment.
On 2/28 I returned to Columbus for a bone scan. (Didn't need a CT
scan because my baseline CTs were clear.) This was a week early on
the published schedule but we wanted to leave for Florida the next day,
and there is a 7 day window, so I was allowed to do it then.
6. Participants are followed for 3-1/2 years, according to the consent form,
so I will be returning periodically for bone scans and blood work.
The trial is "no cost" to the patient -- but of course they do send claims
to medicare and secondary insurance carriers. Whatever they
won't pay, Dendreon does.
First Results!
From: Jack M. Beaven [mailto:mahlonbeav@juno.com]
Sent: Monday, March 18, 2002
6:55 PM
To: hrpca@yahoogroups.com
Subject: [hrpca]
Re: Dendreon/Provenge Phase III trial
Today I received the report from the first
post-treatment bone scan. It was compared to the baseline scan done on
12/27/01.
Essentially, the "Opinion" stated that the
comparison suggests improvement in the metastatic disease, with no new
areas identified to suggest progression.
While it "takes more than one robin to make
a spring," this result suggests (to me at least) that (1) I received
the vaccine instead of a placebo, and (2) the vaccine is having a
beneficial effect. I also think the fact that I had the scan on 2/28
(a week earlier than the "official" schedule) so we could come away to
Florida -- giving the vaccine a little less time to take effect -- is a
further positive sign.
While we're feeling pretty good about this
report, we're not popping any champagne corks just yet. I'm sure not
going to abandon my diet & supplements regime any time soon. :-)
My (green) tea tag tonight says:
"Success is a journey, not a destination."
Update on Jack's Experience with Provenge Vaccine
Trial
as of late July, 2002 through October 28, 2002
From: MahlonBeav@juno.com [mailto:MahlonBeav@juno.com]
Sent: July, 2002
Subject: Re: [hrpca] provenge
Trial news: The FDA had put a hold on
accepting new patients for the Phase III trial for hormone resistant
patients, pending investigation of manufacturing methods, which has now
been lifted, and it looks like Dendreon is again accepting new
participants.A press release from Dendreon gave an upbeat analysis
of the results to date. The patients were separated by gleason score.
My
Gleason, according to Dayton, Ohio area pathologists, both biopsy and
post-op was reported as 6 (3+3). Therefore, I should be a good candidate
for success.
By my interpretation, I haven't had
progression over 5 months time, and if it holds true in September, it will
be 7 months (hope-a, hope-a), which should put me in the"favored" group. I
have had no side effects from the treatment -- I feel physically the same
now as I did before starting the program.
As
we all know, nothing works for everyone, and I have certainly failed to
benefit from several treatments following indications of HRPC status.
Maybe
this is the one that will work for me. At any rate, I do believe that the
final control of this disease will come from some kind of vaccine, gene
manipulation, biological control, anti-angiogenesis, etc.
In the meantime, I'm taking my
supplements, eating right, getting exercise, and keeping my spirits up,
trying to hang on until that day comes.
Most recent bone scan results:
7/8/02
Impression (compared to previous scan on 5/15/02):
1.
Current improvement in previously noted metastatic lesion in margin of
left scapula.*
2. No change in previous focus of
increased activity at T7.
3. Development of an increase in
activity in body of sternum which may represent a new metastatic lesion.
4. Net effect: no significant change
in the underlying metastatic disease process.
*
I acquired this lesion by January of '93 following RRP on 5/28/92 with
favorable post-op pathology reports. PSA at time of surgery was 36, so [I
think] they should have known that the PCa was already systemic.
Water under the bridge. Lesion never
gave me pain, only some discomfort which I originally thought was muscular
in origin, until it became more or less chronic. This discomfort
disappeared, never to return [so far], shortly after I started CHB2 in
July, '93, even though over time it seemed to increase somewhat in size.
All bone scans subsequent to starting CHB until starting Provenge trial
indicated no spread to new sites, and since 10/97 they all indicated that
the lesion was "stable."
So
far I have had a baseline and 3 follow up bone scans while participating
in the trial. They have also shown other areas of activity that are deemed
either arthritic in origin or old traumas from fractures (which I can
verify). I have no pain or discomfort that I can associate with metastatic
PCa.
So
far, I think I am benefiting from the Provenge vaccine, which seems to be
causing some regression of the long-standing lesion on my scapula, and
over-all stability of the disease.
Next bone scan will probably be
September 4th or September 9th.
My
best to all,
/jack
From: MahlonBeav@juno.com [mailto:MahlonBeav@juno.com]
Sent: Monday, October 28,
2002 3:53 PM
Subject: Re: [hrpca]
provenge
I completed the "therapy" phase in early
February, and have had 4 bone scans since. Here is a summary of the bone
scan results.:
[]
2/28/02 seemed to show some regression, but on my closer examination seems
to be only "stability" in the metastatic lesion on my left scapula which I
have had for 9 years, because I don't believe the other areas that showed
regression are actually of metastatic origin.
[]
5/15/02 showed progression in the scapula met, which "might" be caused by
flair due to chemotherapy within the past 3 (or 6) months. Of course I
had no chemotherapy, just the vaccine.
[]
7/8/02 showed regression in the scapula lesion, but also a new spot on my
sternum which was felt to be metastatic.
[]
9/4/02 showed progression in the lesion in the left scapula, progression
in the lesion in the sternum, a new lesion in the left 9th rib
posterolaterally, and a new lesion in the intratrochanteric region of
proximal left femur, suspicious for metastatic disease.
Unfortunately,
this progression was not enough to break the blind, so I still don't know
for sure whether I received the vaccine or a placebo. The site in
Columbus is urging me to have at least one more bone scan before starting
an alternate therapy (I had planned to try AG(aminoglutetamide
- Cytraden)+HC(Hydrocortisone)
again, which had worked for me previously for nearly 3 years, and I have
already obtained a supply).
This
has presented me with a dilemma. If I have further progression (which I
don't want), it may be enough to "break the blind" -- and if I was one of
those on the placebo, I would be able to get the real vaccine on a
follow-up trial because they have saved my dendritic cells for this
possibility. I would, of course, do this.
If
I start the AG(aminoglutetamide
- Cytraden) +HC(hydrocortisone), I won't be able to find out
if I was on the placebo or not. Maybe I would be able to in a couple of
years after all the trial results are finalized, but if I had the placebo,
I wouldn't be eligible for the follow-up trial any more. Thus the
dilemma.
I
have decided to go for the next bone scan on 11/25, and in the meantime
have started on Fred Eichhorn's CELLECT vitamin program, which may have
some benefit and won't disqualify me from continuing on the trial.
My
tea tag this afternoon reads: "Success is a journey, not a destination."
/jack
