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Clinical Trials Question: Did you have to research and bring up the possibility yourself, or was it offered/recommended by MD?

a_oaklee
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Joined: Nov 2013

Our story:  My husband was diagnosed at Stage 4 two years ago.  We have been to two large metropolitan teaching hospitals and also local treatment facility.  We have seen a total of 5 RCC Oncology Docs.  (they keep relocating and getting new jobs).  On our very first visit we were told there are 7 drugs and we will go through each one and after that there is a clinical trial for patients who still have their kidney tumor and are not having surgery that we can look at.  We certainly did not want to be in that trial.  Since then, trials have not been mentioned at all.  My husband has taken Votrient, Affinitor and currently Inlyta.  After reading so much here about people on trials, I asked at our last visit about possible trials to participate in.  The response was that we would talk about that later when everything else is exhausted.  I even mentioned Cabo, Nivo etc..  It's interesting to me that participation is not discussed or encouraged. 

I recently did a trial search online.  I think it's a bit overwhelming. 

Thanks a bunch for letting me know your experience.

Annie

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todd121
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I recommend doing both. I'd research myself and get some ideas, and then I'd go and talk to the doctors that are listed as the point of contact for those trials and get their opinion. For each trial, they list specific doctors at specific institutions as a point-of-contact. I believe those doctors are the best to discuss the trial with. Doctors not participating in the trial probably won't have much knowledge or interest in it. They will go with approved treatments. If you have interest in trials, you need to see the doctors doing research, not just those that are treating with approved treatments. The latter will use the approved treatments until and if they become inneffective, and only then will they recommend a trial. (This approach is also ok, if that's what you want to do).

You can narrow your search a lot by several things. First, by your location and how far you're willing to travel. I knew I wasn't willing to travel beyond a 1-2 hour drive from my home unless there was something that looked really to be likely to be beneficial. Second, many of the studies have a very detailed list of criteria of what patients are admitted to the trial. If you go through those, you can usually figure out if you're qualified for the trial. If it's some criteria that is close and you're interested in the trial, I'd go talk to them anyways. Sometimes they do make exceptions. However, often times it's very clear you aren't eligible. For example, for the trials I looked at, you had to start them within 12 weeks of your nephrectomy and you couldn't have any other evidence of disease.

There is probably some kind of standard of care that has to be tried first before other things can be tried, so the doctor may be required to try the approved drugs first. If you don't want to go that route, it's going to be up to you.

Why not ask the doctor why? I know this can be tough. They are often in a hurry, or aren't willing to have a technical discussion with patients about the reasons, etc. However, you might have to push a little. If you didn't get all your questions answered, I strongly urge you to go back and see your doctor and ask your questions. You should know why you're doing what you're doing and I think you should be sold on your treatment (or at least sold on trusting your doctor). Get other opinions (it sounds like you have and I'd keep it up). I felt better when I saw 2-3 specialists and started seeing a consensus. And by the way, one of those three opinions was actually completely wrong and he was the first one I talked to...

 

Todd

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NanoSecond
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Annie.  Please consider getting a second opinion.

Every time a drug has failed me (twice now) my oncologist STRONGLY encouraged me to find a clinical trial.  Of course I agreed.  However, my stipulation was that I would only consider immune-based therapies (i.e. anti-PD1 or anti-PDL1 or a vaccine, etc.).  He agreed with that strategy.  The main point was that I was still quite healthy and quite able to tolerate a clinical trial.  This is the main reason why you do NOT want to wait until you are completely out of any other options.  If you are too weak or unhealthy they may not let you participate.

Back in December (when it became clear that Sutent had failed me) I tried as best as I could to find a suitable immune-based clinical trial.  Unfortunately, there were none for me.  One big issue was that BMS (Bristol Myers Squibb), makers of Nivolumab, (the drug Fox did so well on) will not allow non-clear cell RCC patients into any of their cohort expansions.  Plus they seem to be moving on to trying their drugs on other cancers such as Lung or Breast.  So I finally had to give up and reverted to starting on an FDA drug, Inlyta.

But when it became clear (earlier this month) that Inlyta had also failed me I got the same advice to find a clinical trial if at all possible.

What happened next will be the subject of another thread.

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BDS
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The following is just my opinion from what I have experienced.

After reading Fox’s posts here on CSN I have been actively pursuing entering ANTi-PD-1 (Nivolumab) clinical trial. I started this quest since shortly after starting treatment in July of 2012. I have discussed upcoming clinical trials with my oncologist at almost every meeting. I have also traveled to two major cancer hospitals outside of my area in order to discuss upcoming clinical trials. The answer has always been the same – No! The reasons seem to fall under the following categories

1.      Patients must be treatment naive for which I am not (For example, the Argros Adapt study using AGS-003)

 

2.      At the time, I was progressing well on my current medication Votrient/Panzopanib. The doctors would not consider having me stop my current treatment in order to enter a clinical trial. Even though that trial I was requesting was Votrient/Panzopanib in combination with Nivolumab.

 

3.      As of now, most clinical trials involving Nivolumab are now no longer recruiting new patients.

 

4.      ANTi-PD-1 Clinical trials may be filled before you are ever aware of them    

 

 

 

I am coming to the sad conclusion that finding clinical trial that would be most beneficial to me is like chasing rainbows. As of now, I feel I am condemned to the standard line of FDA approved therapies. Hopefully, I will still be alive when Nivolumab finally receives FDA approval for renal cell carcinoma (About 2016). - BDS  

 

NanoSecond's picture
NanoSecond
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I hear and echo your frustration.  But don't give up.  I almost did (for the second time as I mentioned earlier) but then serendipity struck...

To make an amazing story short, if the CT-scan of my brain (performed earlier today) comes back clear I will be joining a clinical trial being conducted at the NIH/NCI of a new anti-PDL1 drug starting this coming Monday (24th).

What is even more absurd - I only found out about this clinical trial one week ago.  It had been under everyone's radar - even my high level contacts at the NIH/NCI.

The lesson is you just have to keep researching and calling - and then depend on pure luck.  In my case, my wife and I were alerted to the existence of this trial by Dr. Hans Hammers at Johns Hopkins.  He and his associate, Dr. Mark Markowski, are simply gems.  Like so many other patients of theirs, I can't say enough good things about them.

 

GSRon's picture
GSRon
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Great news Neil. Hope it works for you.! Ron

foxhd's picture
foxhd
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Everybody pay attention. I was extremely lucky for both nivolumab and IL-2. But only because I didn't accept terminal cancer. Effort and knowledge is power. Don't let someone else decide your future. Keep looking and be aware of options. This is about survival. Not curling up and dieing. Become the squeeky wheel.

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todd121
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So glad to hear about this! Hope that scan turns out ok and you start this trial soon.

:)

Todd

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Darron
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Neil

is that the Merck trial?

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NanoSecond
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Thanks to all of you who have expressed your good wishes.  However, I am still a bit superstitous.  I will not hear the results of my CT brain scan until Monday morning.  If it is clear I will be checking into the NIH/NCI hospital that same afternoon.  I will get my first infusion of an anti-PDL1 made by EMD Serono (not Merck) on Tuesday morning.  Then I have to stay in the hospital for observation until Thursday morning.  Future infusions will not require any hospital stay - just the initial one.

My advice to anyone looking for an anti-PD1 or anti-PDL1 trial is to concentrate on BMS's competitors - Merck (as mentioned by Darron) but also Genentech and MedImmmune.  They have or will be introducing new clinical trials over the next few months.  Many of them will be dose escalations studies (such as the one I hope to start on) but a few will be cohort expansions (which may be more restrictive).

Here is my trial - but I believe it is no longer open to RCC patients:

http://www.clinicaltrials.gov/ct2/show/NCT01772004?term=emd&rank=101

Finally, there is one bit of bad news.  If I start on this trial on Monday I will have to cancell my trip out to San Diego to attend the 2014 AACR (American Association for Cancer Research) Annual Meeting.  That means I won't get to meet Ron (or anyone else attending from CSN or SmartPatients).  That is extremely dissappointing.

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BDS
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Dear Nanosecond 

            Normally I really really do not like posting the names or conversations that I have had with doctors on the internet. But in this case I am really going to make an exception. I met with Dr Hammers on March 20th about possible entering the clinical trial of a Nivolumab and rIL-21 at John's Hopkins. As my luck would have it the trial was canceled/pulled by BMS the day before our meeting (And you wonder why I am frustrated!). Dr. Hammer told me for my next treatment  I had three options 

1.     Go on Axitinib/Inlyta

 

2.      Go on HD-IL2. I can tell that my current oncologist is dead set against HD-IL2. I know when I suggested that I am now considering this option she will hit the roof. 

 

3.      Wait for a possible clinical trial that I may or may not be eligible for involving Merck PD1 and CTLA4. Has Dr. Hammers put it  - "I do not want to I do not want to dangle a sausage in front of you". (Very German Laughing) He said he would let me know if I was eligible within a week.   - BDS

NanoSecond's picture
NanoSecond
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Yes, I had heard of last minute cancellations of several trials.  That's when I was about to give up. 

The trial I am (hopefully) about to start on had a very last minute change and opened up for just a few more participants.  That is why it was under everyone's radar and why I say that a very large part of finding a suitable trial comes down to dumb luck. Unfortunately.

Still, did you look into this one?  It is temporarily on hold:

http://clinicaltrials.gov/show/NCT01441765

 

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Darron
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To Neil's point, when I first started Nivolumab, it didn't have a name. It wasn't the drug that everyone wanted to take. I had to fight with my urologist because the doctor I wanted to see was involved with immunotherapy and melanoma. He wasn't a kidney specialist In my urologist's eyes. Keep in Mind these two doctors practiced in the same hospital system and had offices less than 12 miles apart.

My thought supports what Neil and Fox are saying. Keep looking and be open to finding any answer. If you narrow your search to one thing, you will only find one thing. Be open.

Along those lines, look for the Merck Anti PD-1 drug. there was a press release lately that it now has FDA special approval for use in melanoma. Nivolumab wasn't successful enough to gain that distinction. I believe I saw that they will soon open the drug to RCC trials. My doctor was more excited about that development than he was about Nivolumab. I saw the article at onclive.com, but I didn't follow up with any search for locations or time frame of when it will be offered. 

I also agree that if your doctor isn't involved in trials, he most likely won't be a big seller of trials.

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foxhd
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In agreement with your last statement. I also believe that when a pc or urologic surgeon says that,"You don't need an oncologist." I get shivers. Kidney cancer just is not their specialty. If you wanted to learn to play piano, you wouldn't call a plumber. We have seen this too many times here. Get the right people to help. That is what they do. You just have to find them.

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GSRon
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Neil, and here I was all set for you to be my dinner date in Sunny Eggo...  But, the start on the new treatment has to be a much better date than me..!!  I will try to share what I learn...  I am thinking great thoughts for you...  In my family, Mondays were thought of as good days... and Thursdays are even better... sigh...  Hang in there... hope this treatment does in the Crud..!!

Ron

one putt
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I have  been in the nivolumab/votrient trial since May,2012. It was recommended by my oncologist Dr. Hans Hammers. He mentioned the trial at our very first meeting in Oct. 2011, before I had my nephrectomy. I have praised him many times on this board, and consider myself very fortunate to have him as my doctor. It's really good to see others having such a high opinion of him. He truly has changed my life.

Neil, that is great news. If your appointment with Dr. Hammers is still on for the 27th I'd like to meet you, schedules permitting, and buy you a bottle of water (or whatever your drink of choice is these days).

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NanoSecond
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Well I'd love to take you up on that offer.  However, that appointment was cancelled when I got to see him earlier.  If I had not gotten into the clinical trial I was slated to see him next on April 17th.  But if I start that one will be cancelled too.

But certainly one of these days we should be able to cross paths.  I'll let you know when my next visit may be.

Looking forward to it.  Water will have to do.  That or green tea.  I can see Fox is cringing because he thinks it should be over a beer...

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foxhd
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....no pizza?

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NanoSecond
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Well I just can't seem to decide which is worse.  Beer offers all those excess carbs (that's the major problem; not the alcohol) and pizza is heavy on carbs (starting with the dough made from wheat) plus all that added sugar (in the tomato sauce).  The cheese is quite healthy but only if it comes from a grass-fed cow; same goes for the pepperoni and sausage. It's a tough choice...  :)

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foxhd
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There's none left!

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GSRon
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Fox delivers... again... funneeeeee...!  Laughing

Ron

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NanoSecond
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Damn.  I forgot about the anchovies.  They are totally healthy.  Plenty of long-chain omega-3's and a great source of calcium.  How about a Ceasar Salad instead?

 

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GSRon
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Anchovies..??  Really..??  Talk about a sodium rush..!  Well, maybe not...  so just for grins, I looked up Anchovies.. and found a link.. a wonderful link..  and this is a must share for anyone trying to reduce their sodium intake..  I bring you.. "Sodium Girl"...   :)

http://www.sodiumgirl.com/low-sodium-anchovy-substitute/

Ron

 

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NanoSecond
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Ron.  If you research all the issues regarding sodium you may be surprised to discover that it is not so evil after all.  Just be careful out there.

I love anchovies. And sardines for that matter.  Small fish like these do not have high levels of heavy metals like Mercury.  That is why they are the perfect source for your omega-3's.

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Darron
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What Neil Wrote:

 Pizza or Beer?

Well I just can't seem to decide which is worse.  Beer offers all those excess carbs (that's the major problem; not the alcohol) and pizza is heavy on carbs (starting with the dough made from wheat) plus all that added sugar (in the tomato sauce).  The cheese is quite healthy but only if it comes from a grass-fed cow; same goes for the pepperoni and sausage. It's a tough choice...  :)

What Fox read:

Beer offers alcohol. Pizza is quite healthy. Same goes for the pepperoni and sausage. It's a tough choice.

I must say Neil, your diet is well researched, proven, and obviously a great decision to help the effectiveness of all the meds we take, but you must remember what I said on the earlier post:

YOU WILL FIND ONLY WHAT YOU LOOK FOR.

Need I say more about Fox's response?

I myself enjoy fruit for breakfast, a Kale salad for lunch and a sensible dinner during the week. I'll have a pint or two and some pizza on the weekends.

Moderation in everything we do is important.

You guys are both great!

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NanoSecond
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Of course I agree with you Darron.  I just enjoy interacting with Fox.  We both come at this "situation" from very different perspectives. 

I really have no issue if someone decides to enjoy a pizza and beer every now and then - especially as a celebration.  The real issue is stress relief after all.

But as for me - based on what I now know about how cells operate - well, I just can't do that ritual anymore. 

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foxhd
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of my personna. Is that the correct usage of the term? If I ate pizza and beer every time I said I did, I'd have to change my name to "Jobba the (pizza) Hut." I spent over 30 years involved in sports training and performance enhancement. I've worked with elite athletes.  I could chart out the krebbs cycle. I knew cellular metabolism cold. I've also worked with and watched hundreds of people deteriorate and die. Kidney cancer is new territory for me but life and death isn't. No one gets out alive. We all die from something. If my number is coming up, I want to enjoy every last minute of my remaining life. (again, reaching my 60's helps with this philosophy.  I feel terrible for everyone younger.)

Now don't get me wrong. I want to live much longer. And I can put up a good fight. But an extra taco isn't putting anyone 6 feet under. Not us anyway. I believe in the current medical model. I am alive because of it. The malfunction in our kidney  programming is the culprit. It is not having lung cancer from smoking 2 packs a day. Health nuts get kidney cancer too. It's not our fault. Vegetarians die daily. Nutritionists die daily. And they don't live longer than the guy next door. There are always exceptions. Some cultures with specific diets do live longer. But that is also in their genetic make up. Our genetic coding was handed down to us from previous generations. Can't change that. Fitness experts die daily. Jim Fix was still running up to 10 miles a day with advanced heart disease until he died. He could only have lived longer with surgery and modern medicine. Diet did not kill him. Or lack of exercise. It was his genetic make up.

I applaude Neils mind and committed effort. Awesome stuff. Everyone can learn so much from him. He is the role model to emulate because he is using his brain alot more than the rest of us. The stratetician. Neil knows things his doctors haven't even thought about. If you want good medical care, let your doctor know you are smarted than he/she is. Keep them on their toes.  I look at my cancer as a population out of control. It must be executed. I don't think we can starve it to death. Give me surgery, drugs and radiation. Then I'm going out for a beer! Maybe a calzone. I like to vary my diet.

Our first step at killing cancer is surgery. Get rid of it. It was too late for me. Like Vikings, it had already set sail for new lands to dominate.   I decided that I would ride it like I stole it (biker reference)and die a happy man when the day came. Living retired means that I think much less. I smell the roses. I pet stray dogs. I find what gets overlooked and enjoy the good in it. I smile alot. I believe in the course of action of my doctors. Who by the way are also a LOT smarter than me. If my caregivers can't eliminate the cancer I'm out of luck. Fortunately, they are on the right track. I am reassessing how I spend my remaining life. But eliminating pizza and beer isn't one of them.

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NanoSecond
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Well Fox, if I had one-tenth the enthusiasm and super-human drive that you possess I would not worry about my diet either.  Seriously.

I have never made the claim (nor would I) that any diet (or any lifestyle change such as exercise) - alone - can cause or greatly alter the course of cancer.  Although it might help prevent it for those who are otherwise healthy.  No one can say.  Yet.

However, what I have set out to do is the exact same thing as you - maintain my quality of life and health as best as possible in the face of a clever disease and incredibly powerful drugs and therapies.  Since joining the club that no one wants to join I also have tried to answer a simple question - what is the best diet for anyone facing advanced (or not so advanced) cancer?  In the course of my research I have changed my thinking about this on numerous occasions.  I expect I will continue to do so as I learn new things.

Finally, you categorically state that you "believe in the current medical model".  Well so do I.  But I just happen to spend time trying to figure out what that medical model is going to be in 5, 10, or 20 years from now and then act accordingly - since the odds are I am not going to be around to make it that far.

No matter what, though, I do not believe that the current medical model has been endorsing anyone to follow the "standard American Diet" (SAD).  The "experts" may not agree on what to replace it with but that is a discussion for another day and likely another website.

Meanwhile I truly admire your indomitable spirit Fox.  And if eating pizza and beer is responsible for it; who am I to judge?

I am alive
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Cool

I am alive
Posts: 288
Joined: Jul 2012

My fellow chromieWink

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Jojo61
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Guys, I find this news very exciting! (about the new trials, not the beer/pizza/sodium stuff). I am fortunate enough to not have to be concerned about trials at the moment (fingers crossed that this continues) But you guys are stellar examples for us all to never give up. You are amazing people and I am proud to be associated with you. I wish I had the brain power you guys have, to understand all this medical jargon, but I don't. So I will settle for cheerleader. YAY TEAM!!

Hugs,

Jojo

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GSRon
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Diet... oh my.. we all have our opinions..  Initially post surgery March, 2012, I decided that I would have only one meal a month with red meat.  In reality I had often gone several months without red meat.  I did not miss it..!  OK, so Neil said that maybe this was too much a reduction.  So just over 2 weeks ago, I added red meat twice a week.  The last 4 or 5 days, it is interesting that my blood pressure is now lower than it has been.   When my B.P. dropped to 95/60 I cut back my B.P. meds.  My average B.P. (on Inlyta) was 130/95.  Now there is NO science behind any of this, just a single person observation.   I still watch my sodium intake.. I get plenty of salt.. more than needed. Reduction not elimination is my sodium practice.  

Now it has been about a year since I have had any pizza.  And I know the exact date I had my last beer.. it was last August on the Isle of Man.  Will have another beer this August..!  Oh yes and a taste of red wine about a glass a month.   I just do not miss any of that stuff...  well I did have a craving for pizza when it got mentioned here... just did not do it.. yet.  

Stay Well All..!!!

Ron - 5 months until the Isle of Man..!! Laughing

a_oaklee
Posts: 265
Joined: Nov 2013

I have been away for awhile, but have kept up reading all the responses.  I didn't want to write using my cellphone, if you know what I mean?  I was so impressed with the vast amount of information shared by you gentlemen.  You guys are the greatest!  I learned so much from your personal quest for clinical trials. Thank you for sharing with me and others.  You guys are something else...haha....start out all "smarty" and "clinical"....and end up with pizza and beer.  Gotta love that.  Where's the party?

BDS:  We've heard the same things you have heard.  Particularly that you don't stop what is working.  Been on Inlyta for 1 year and going strong.  Maybe I shouldn't even be thinking "what's next for us?" 

Neil:   I am excited for you being in a clinical trial and I really hope that you are doing well.  Congratulations.  I look forward to great success for you.

You gentlemen are the best! 

Annie 

NanoSecond's picture
NanoSecond
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Many thanks Annie.

Right now I am writing this from the NIH Hospital in Bethesda.  I have to stay here until tomorrow morning for observation.

Yesterday morning I got my first my first infusion of an anti-PDL1 drug made by EMD Serono (a division of Merck in Germany).  The infusion itself was uneventful.  It took about one hour.

About 4 or 5 hours after the infusion ended I developed a fever of about 102.1.  This, actually, is pretty normal for this drug.  I initially declined to take any Tylenol to lower my fever because I have read research that showed that if a tumor becomes inflammed it will actually draw in more activated T-cells.  Of course there is no guarantee that the fever was due to that but one can fantasize...

I finally did take some Tylenol prior to going to sleep.  It brought my temperature down to about 101. But this morning my temperature and all vital signs are back to normal.

Other than seeing a large pink elephant flying around my bed yesterday there were no other side effects.

 

 

a_oaklee
Posts: 265
Joined: Nov 2013

I'm very happy for you that you successfully got into a AntiPDL1 trial.  I hope you remain comfortable.  I always appreciate the knowledge you share.  You must really keep the doctors on their toes.  How's the hospital food? 

NanoSecond's picture
NanoSecond
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Joined: Oct 2012

Well Fox would like love it since he can have all the pizza he wants.  The food actually tastes good but it is very hard for me to come up with a low carb diet based on the choices in the menu.  So my wife has been bringing me "adjuvant therapy".  Luckily I will get out tomorrow.

The nurses here are really on the ball though.  Several of them want to know all about low carb diets and why they are the healthiest.  They are very open minded which makes me quite optimistic for the future.

The ironic part of my stay is that I am in the middle of reading a wonderful history of Immunology starting with Coley's Toxins and ending with a detailed history of the introduction of HDIL2 therapy - right here at the NIH by Dr. Stephen Rosenberg and his cohorts.  I even saw him strolling down the hall a little while ago.

If anyone wants to understand why HDIL2 remains rather controversial to this day I highly recommend reading, "A Commontion in the Blood" by Stephen S. Hall.

a_oaklee
Posts: 265
Joined: Nov 2013

"Adjuvant therapy"...haha.  Nice term for sneaking in food.  Im so glad she's there to keep you company and bring the food that you want.

I'm sure the nurses find you to be a very interesting patient considering the vast amount of knowledge that you have.  I checked out that book on Amazon.  I was wondering if it would be very technical and beyond my comprehension.  But alas, the reviews said it was very well written and not difficult to understand.  Do you have other titles of books you care to share?  I think it's free shipping on orders over a certain dollar amount!!  Haha.

Question re trials:  Does a participant need to have "active" mets to be in trials?  Someone wrote that "they" need something to measure.  Or are all trials different?

NanoSecond's picture
NanoSecond
Posts: 656
Joined: Oct 2012

Hi Annie,

First of all, the book is extremely well written and no more "technical" than the Pulitzer prize-winning, "Emperor of All Maladies". You will not find it difficult to follow at all and probably far more interesting.  I just wish it did not stop in 1996 (when it was written). So much has happened since then.

I have a pile of books yet to read.  So this 3-day hospital break has given me the opportunity to start catching up on some of them. In my guide to nutrition I mention all the books that I have found useful (so far) in investigating nutrition and now, immunotherapies.  So if you would like the latest version just let me know.

Yes, you do have to have active mets to be in many of these trials.  And those mets have to be large enough to be measured.

Finally, yes, the protocol of each trial is different and must be adhered to.

 

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