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Clinical Trial - Round #3

Posted: Thu Nov 20, 2014 6:07 pm
by NWgirl
Just a brief update on round #3. I waited 2 weeks from the last infusion to get this one. Ideally they would like it weekly, but I just can't do it.

Treatment was pretty much the same - tons of anti nausea drugs, the trial drug and then check in at the hospital. The nausea/vomiting started around midnight or so - about the same amount of time it took the last time to hit me. Thankfully I didn't have any diarrhea to speak of, so that wasn't too much of a problem. I had put on a brand new bag that morning hoping the seal would hold out - and it did. I had some sort of heart monitoring device on me at all times. It only went off once when I had to go to the bathroom and empty my bag and pee - you know how much that gets your heart rate going - lol! :lol:

I think I vomited for several hours. I think I got into a big argument with a nurse over why - with a port - they had to access a vein in case something bad happened and I had to go to ICU and they would be mad if I didn't have 2 "life lines". I think I may have had some pain issues at some point (according to my friend who was with me) but for the most part, I don't remember much of what happened once - as they say - "the shit hit the fan" or something to that effect.

I ended up staying 2 days in the hospital (Tues night thru Thurs a.m.) or 3 if you want to count Tuesday as a day. On Wednesday I spent the entire day and night sleeping - I don't know how I could have slept that long, but I did, and I evidently needed it. I'll have to ask my friend to fill me in on details - I really don't remember much of what happened or what I said.

My oncologist has been checking my CEA weekly and it drops by about 5 points every week - so that's good - right!? That's what I need to see to give me the courage to do another round of this drug. But it won't be for another 2 weeks because I don't want to be sick on Thanksgiving week!

Re: Clinical Trial - Round #3

Posted: Thu Nov 20, 2014 6:49 pm
by peanut_8
Belle, I can't imagine doing that once a week. Every other week is still quite a lot. The dropping CEA levels sound really encouraging. Hopefully that will continue. How long does the trial go on for?
peanut

Re: Clinical Trial - Round #3

Posted: Thu Nov 20, 2014 7:08 pm
by NWgirl
I'm not sure how long the trial will go - I'm not sure they've decided yet.

I meant to mention that a trial for this drug will start at Duke University soon (may have already started) and will soon open at a couple of other sites - but all on the East Coast. Only this one in Portland on the west coast. If anyone wants the names of the other sites, let me know. Now that you know the side effects, you'll know it's not fun. I have a CT coming up December 2nd - so once I have the results, I will of course post them here. Immediately if they're good; and if they aren't good, I'll post them after I've numbed my emotional pan with a nice glass of wine (or bottle of wine) or someting quite similar.

Re: Clinical Trial - Round #3

Posted: Thu Nov 20, 2014 7:29 pm
by weisssoccermom
Belle - I know that this can't possibly be any fun BUT....it does seem like you are getting some results. I don't know what your CEA is but 5 points can be a significant percentage drop in that test. Whatever the percentage is....the facts are simple. Your CEA IS going down and you have always said that CEA is a good indicator for you! I don't think I would worry about the weekly vs every two weeks schedule. What matters is the test results indicate the treatment is doing something POSITIVE and that's what counts.

You are truly an inspiration to everyone Belle. I'm so proud of you for taking this trial on. Take care. Get some rest so that you can feel better for Thanksgiving.
Jaynee

Re: Clinical Trial - Round #3

Posted: Thu Nov 20, 2014 7:33 pm
by NWgirl
CEA at the start was 64; it is now down around 59 as of last weeks blood work. :D

Correction - it was 64 and its dropped around 15 points so it must be closer to 49.

Re: Clinical Trial - Round #3

Posted: Thu Nov 20, 2014 7:55 pm
by midlifemom
Belle, you are amazing. Thank you.

Re: Clinical Trial - Round #3

Posted: Thu Nov 20, 2014 8:30 pm
by teachpdx
Belle I'm sorry that you have to go through this, butt you are getting results. Good thing you are in the hospital and you've got someone with you that can tell you what happened.

Hope you feel better soon. Peace :wink: Kristi

Re: Clinical Trial - Round #3

Posted: Thu Nov 20, 2014 8:41 pm
by bitchslapped
You know I must be missing just what trial/drug you are in by postings. If you've posted it somewhere, please excuse me, but couldn't find it. Has there been any talk about adjusting each dose vs spacing time between dosing? Isn't this a Phase I? You'e mentioned they would like you to come every week, but the side effects sound so severe for you, it is understandable.

Bitchslapped

Re: Clinical Trial - Round #3

Posted: Thu Nov 20, 2014 9:06 pm
by DK37
To echo another comment Belle - you are AMAZING.
Thank you again for being such a trailblazer!
BTW Sometimes with immuno drugs the effects on CEA and CT can happened in a delayed fashion (compared to how those tests behave with chemotherapy). This is something that people in the early CTLA4 clinical trials had to get used to - some long term highly responsive patients didn't necessarily have the instant CT-scan shrinkage results seen with some other types of drugs when "they work". Sometimes tumors even appear to swell slightly if infiltrated with a lot of immune cells but a good radiologist should hopefully be able to tease out that effect.
I think it is GREAT NEWS your CEA is already dropping!!!! Based upon other immunotherapies, a 5 CEA drop may actually appear less than the actual real clinical benefit you might be getting. But since you are patient #1, all are guesses at this point how this particular therapy will behave. Swinging chickens for you big time!!! Take care-

Re: Clinical Trial - Round #3

Posted: Thu Nov 20, 2014 9:59 pm
by orcasres
Belle,

It takes a lot of courage to face this every two weeks. Thanks for doing it. Lois

Re: Clinical Trial - Round #3

Posted: Thu Nov 20, 2014 10:03 pm
by jens22
Belle....you are amazing!!! Inner strength is incredible. I hope the next one lets up on the nausea!!

Re: Clinical Trial - Round #3

Posted: Thu Nov 20, 2014 11:58 pm
by NWgirl
bitchslapped wrote:You know I must be missing just what trial/drug you are in by postings. If you've posted it somewhere, please excuse me, but couldn't find it. Has there been any talk about adjusting each dose vs spacing time between dosing? Isn't this a Phase I? You'e mentioned they would like you to come every week, but the side effects sound so severe for you, it is understandable.

Bitchslapped


The drug is MGD007 and the mfr. is Macrogenics and yes, it is a phase 1 trial.

I don't know if reducing the dose is an option. I always mean to ask and then when I'm there I forget.

Re: Clinical Trial - Round #3

Posted: Fri Nov 21, 2014 8:00 am
by Asterix
Thank you Belle for your updates. I do hope you get good results from this drug.

Re: Clinical Trial - Round #3

Posted: Fri Nov 21, 2014 10:09 am
by lorrainem
Glad this round is over; and with CEA going down, glad results at least make the big house confinement and resulting ugliness worth it. I'm thanking you also for this, but most of all I love your fight!

Re: Clinical Trial - Round #3

Posted: Fri Nov 21, 2014 11:42 am
by trapbear
Belle,
Thank you for the updates, so sorry you are having so much nausea with this new drug. Hang in there, I hope your numbers keep on dropping.
Hugs,
Bill