Termination Appt. and What Did You Switch To

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby CureOrBust » Mon Jan 12, 2009 6:14 pm

Lars wrote:2nd Edit: I just spoke to a someone at Genzyme and I quote (to the best of my ability) "The principle investigator at each site has the final word on inclusion/exclusion criteria".
I was vetoed by Genzyme themselves. The nurse / research assistant at one trial centre sounded on my side, and contacted them, then got back to me. I was vetoed by Genzyme because I was on Rebif for only 4 months.

I am being now considered (although I think its more of a case of being messed with) by another trial centre (where the principal investigator is an associate of my neuro). My neuro scoffed at the fact that I was rejected by the other trial centre because I was only on rebif for 4 months and not 6. He appeared arrogant to me, in the way he felt it was up to him, who and who does not get included. So, I will see.
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Postby patientx » Mon Jan 12, 2009 6:21 pm

That brings up a question I had for ssmme: Which version of the Campath trial did you join, CARE I or II?
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Postby Lars » Mon Jan 12, 2009 6:43 pm

Cure,
I really haven't had the inclination to learn the "quote" thing but here is yours;
"He appeared arrogant to me, in the way he felt it was up to him, who and who does not get included. So, I will see."

I think what I was told today verifies what you felt, he may be arrogant but it may be justified, I think it IS up to him. By the way I have been on nothing at all except Tovaxin, does that dictate what study I would be (by grace of the trial gods) put in? I really think it would be in the interest of us and the study for someone to make an across the board decision on the Tovaxinites
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Postby CureOrBust » Tue Jan 13, 2009 1:47 am

Lars wrote: I really think it would be in the interest of us and the study for someone to make an across the board decision on the Tovaxinites
The original research assistant / nurse I spoke with seemed to me to be the perfect person for this task. she collected my information and my interest in participating within the trial, then presented it to Genzyme. I am sure once they make a ruling at one site, they would be consistent between sites; until they needed to reverse it (eg if they had trouble filling all the places)
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Postby ssmme » Tue Jan 13, 2009 6:36 am

Which version of the Campath trial did you join, CARE I or II?


CARE II

My thanks go out to Mike Tucker who's knowledge has led to our trial site being able to let former Tovaxin lab rats into CARE II. This includes everyone from tovaxin whether or not they got the real vaccine during the trial or in the extension study.
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Postby patientx » Tue Jan 13, 2009 7:41 am

That's interesting. As I understand it, the CARE-MS II trial is for people that relapsed while on one of the CRABs. and the CARE-MS I is for people that have never tried anything. It would seem that the refugees from the Tovaxin trial are sorta stuck in the middle.

Did you try one of the CRABs before the Tovaxin trial?
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Postby ssmme » Tue Jan 13, 2009 8:17 pm

Did you try one of the CRABs before the Tovaxin trial?


No, I was newly dx'd and went straight into Tovaxin. My clinical research staff said that being treated with Tovaxin places us in the CARE II arm of the study. I did have a confirmed relapse after my 4th and final OLTERMS vaccine which places me with all the necessary criteria to get into CARE-MS II. They are considering a relapse on Tovaxin to be the same as relapsing on the CRAB's for acceptance into the study.
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Postby CureOrBust » Thu Jan 15, 2009 7:01 am

Lars wrote:...I think it IS up to him...
I heard back from the associate neuro of my neuro. I was rejected for the trial because I failed three entry/exclusion criteria. My neuro will also be running a trial for Campath as well. We'll see if he will include me.

Three criteria? Ok, one definite, the 2nd I can also "understand", but I can't remember a third :?
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Postby flipflopper » Sat Jan 17, 2009 10:54 am

I just wanted to spend a few minutes on this thread. I wanted to withdraw from the extension study at the end of last September but I still have not started a new drug.


I have had ms for quite some time. I have tried Rebif but I really don’t tolerate interferons and I was on Copaxone for 5.5 years before enrolling in the Tovaxin trial. I didn’t feel like Copaxone was doing much and I have no interest in going back to Copaxone.



This all means that I qualify for Tysabri. I have about one relapse per year but I take 6 months to recover from it (this makes this disease very disruptive in my everyday life). Moreover, my MRIs always show a lot of activity. That is why I am currently waiting for my MRI appointment (I live in Canada and it takes months!) and then I will be trying Tysabri.
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Postby Lars » Sun Jan 18, 2009 10:48 am

I'm sure most of you already know this but I did not. Care 1 is 2/3 chance of receiving Campath, Care 11 is 4/5. I would love to have contact info for SOMEONE who has approved us Tovaxin patients. I am still getting NO attention from my closest site and what little feedback I have received was that IF I were to qualify I would be in Care 1. Mike, where are you? I've fallen and I can't get up.
Take Care,
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Postby ssmme » Tue Jan 20, 2009 7:25 am

I would love to have contact info for SOMEONE who has approved us Tovaxin patients. I am still getting NO attention from my closest site and what little feedback I have received was that IF I were to qualify I would be in Care 1.


Lars,

Mike and I (I hope he doesn't mind me speaking for both of us) go to a clinic in Lexington KY called Associates in Neurology. Mike only goes to them for clinical trials. His everyday neurologist is not with the practice. Dr. Cary Twyman on the staff is the doctor that has a big interest in MS. He's the doctor that pretty much decides which clinical trials will be carried out there. They have a very knowledgeable research staff and I have enjoyed the opportunity to discuss everything I learn (mostly through cyber space) with them. They don't "pooh pooh" ideas that aren't mainstream and they don't push any one of the main treatments so I don't think their in cahoots with any of the major drug companies. They do believe patients need to be on some form of treatment though. I don't have their contact info in front of me but google twyman along with city state on the internet and you'll find what you need to contact them.

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Postby Lars » Tue Jan 20, 2009 8:15 am

Thanks Marcia,
I think I have made a decision to go through the CARE application again and try to get involved with the Denver site. I think my feelings about patient care took a huge hit from Opexa and I don't want to involve myself in a trial site that behaves this way. I think that a research coordinator's job speaks for itself and I have seen absolutely no research nor coordination from the N.M. site. In the spirit of inauguration day, I think Genzyme needs an oversight committee.
Thanks for your help,
Lars
Marcia,
I just got off the phone with your site.... I wish I lived in Kentucky. I just got more attention and information in 5 minutes than I have gotten in 2 months from my site. They were very interested in how I got their contact info, I took the 5th. The apparent difference (beyond their obvious commitment to you and Mike) is that they are a private site with far fewer hoops to jump through. They are going to try to have the project manager call my site! Wow, you rock and so does your site.
Thanks again,
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Postby ssmme » Tue Jan 20, 2009 11:57 am

I just got more attention and information in 5 minutes than I have gotten in 2 months from my site.


Lars,

I'm so glad you called them and I'm glad they gave you the information you were looking for. Hopefully they will contact your site and guide them in the right direction. I feel fortunate to have this clinic to help take care of me.

Good luck!

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Postby patientx » Tue Jan 20, 2009 12:13 pm

That clinic sounds awesome. I'm curious - when you were in the Tovaxin trial and even now, do you see your neurologist every time you go in?

With the study I'm in now, it's blinded, so a different neuro comes in to do the exam. But I think he's competing with himself to see how fast he can get the exam done and get out of the room.
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Postby Lars » Tue Jan 20, 2009 12:25 pm

X,
Was the question for me or Marcia? My Tovaxin site was Colorado Springs, Co. and I haven't seen my Neuro since termination (bad patient).
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