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Posted: Mon Oct 13, 2008 6:24 pm Post subject: Tovaxin trial monitoring arm
Howdy - I'm brand new to this website and forum but I've been emailing with someone else in the Tovaxin study in Chicago who let me know about this site. I know I received the vaccine during phase IIb, but I've been testing negative for MRTCs ever since and have one last monitoring blood draw in mid December, results expected right after Christmas. I actually had my second attack during the monitoring arm a few months ago and they tested my MRTCs during that attack and they came back negative which I thought was a bit extraordinary, but it was a very mild attack. Are there other people in this forum who are vaccine positve and in the monitoring arm like me and continue to be MRTC negative? Any thoughts on what to do conventional treatment-wise if you continue to be MRTC negative after your last monitoring arm visit and you are released from the study?
Joined: Sep 16, 2007 Posts: 77 Location: Chicago, IL
Posted: Tue Oct 14, 2008 7:19 pm Post subject: Re: Tovaxin trial monitoring arm
HEC wrote:
Any thoughts on what to do conventional treatment-wise if you continue to be MRTC negative after your last monitoring arm visit and you are released from the study?
Hi HEC and welcome.
Why would you be released from the study? I thought they just watched you and kept bringing you back. It does not make sense to me to kick out people who successfully kicked the t-cells' asses. Please educate me!
Hi Patrick! I love that I can email you on two websites now! My study coordinator told me that if you don't test positive after the third try, you have missed the vaccine window as there is nothing for them to use to make new vaccine. If I test negative again in December, I'm out. I don't think they've provided any protocol guidelines to my coordinator yet as to what happens when you guys are done with this series of injections - you will likely be monitored like I'm being monitored now. I have the monitoring arm consent form at my office - I'll take a look at it again tomorrow to see if it spells out what ongoing obligations there are. There are no MRIs in the monitoring arm I'm in right now (I think you guys don't have many MRIs this time around either since you all know for sure you're getting the vaccine) so I've asked my neurologist to have a separate appointment with me to do my yearly check in with an MRI of my very own that we can compare to last year's check in, and that will happen on my last clinical trial visit day, 12/12. The other vaccine peep in the Seattle group who continues to test negative like me also goes in for his/her final blood test on 12/12. We should have our results shortly after Christmas.
I am in the same boat you are but I have no options for treatment left except chemo....and I am not getting any info from my site coordinator.
I am sitting on pins and needles right now waiting for the results of my 3rd re-draw but I have a monitoring appointment scheduled for Jan 7th if I test negative. There was no mention of me being kicked if I tested negative again....
After my first draw for the extension study, about 2 weeks, I had an exacerbation which was severe enough that I was not able to travel the 450 miles to the trial site. I was seen by my local neuro who evaluated me and made the call that I was having an exacerbation and started me on IVSM. I have had 2 re-draws since - one the end of June and one 3 weeks ago today. That is the one I am currently awaiting the results.
The test results used to come back in 2 weeks or less, but I was informed that it now takes 3+ weeks.
April and June only took a week!
Like Patrick, I am curious about your comments...enlighten us! and Welcome!!! It's nice to have another Pac NW lab rat here!! _________________ Tovaxin Lab Rat
Posted: Mon Oct 20, 2008 9:22 am Post subject: Tovaxin monitoring arm update
Peeps, I stand corrected, I received an email from my clinical trial coordinator who says my blood draw on December 12th will be considered my 2nd of 3 visits to test MRTCs. (this excludes the screening visit that happened for all of us when we finished the last phase). If I'm positive in December, or at the next one in March 2009, I can still transfer into the treatment arm. If you’re negative at the 3rd (in March 2009) there is a 4th visit that would be the final visit. No news as to what the next stage of monitoring will be if I continue to be negative. I'm assuming they are noodling that out.
Recap for me with dates:
6/13/08: this was my last visit for the last phase of study which included MRTC screening to determine if I would go into the vaccination phase again. Tested negative. I had a very mild relapse in mid July (received no treatment, resolved on its own in a few days) and was tested for MRTCs, negative again.
Monitoring arm visit 1: 9/23/08, tested negative
Monitoring arm visit 2: 12/12/08
Monitoring arm visit 3 (if negative at #2): March 2009
Monitoring arm visit 4 (if negative at #3): June 2009 (52 weeks total)
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