AE37 Vaccine Trial - for recently treated high-risk patients

I have my fifth injection on Friday and then the sixth in three more weeks. The vaccine seems to make my lymphadema flare. Anyone else have this?

Momof2 - here is the deal on the HLA (tissue) typing - it is the kind of tissue typing you would have done if you were having an organ transplant, and is independent of blood typing.  You are not HLA positive or negative for purposes of this trial, it is specifically the A2 histocompatibility they are looking for.  The trial includes both Apos and Aneg HLA types.  Those who are A2pos are sorted into the GP2 peptide/sargramostim arm of the trial, those who are A2neg are sorted into the AE37/sargramostim arm.  Both arms are for those who express Her2+++.  They discovered that the AE37 arm may also be beneficial for those who express Her2 at lower levels because the AE37 peptide seems to have a broader effect.  So they must type you histologically, and only if you are A2neg will you be accepted because those folks go into the AE37 arm of the study.

momof2 - I know what you mean!  Fortunately, I worked in Transfusion Services prior to BC and one of my co-workers left and went to work for the local lab that handles tissue typing for transplants in theTampa Bay area.  She helped explain it to me and also tissue typed me in advance so I would know which arm I would be sorted into.  I am A2pos, so I am in the GP2 peptide arm.  They drew blood and typed me again at enrollment but at least I had some idea of where I would end up prior to the start.  Here is a link with some more info, I love the reference to AE37 as "promiscuous", the second link specifically mentions the benefit for those who express Her2+ at lower levels.  The second link is a PDF file so I am not sure how to make it live but you can copy and paste it into your browser and it will take you to the file.

http://www2.mdanderson.org/depts/oncolog/articles/13/1-jan/1-13-1.html

www.abstracts2view.com/sabcs11/viewp.php?nu=P1-13-01

Making my 5th trip down to Maryland on Sunday for my Monday morning appointment. My dad is driving me down and then I am flying home this time.

Anyone else newly enrolled?

I am so thrilled and grateful I am able to do this trial. I miss my kiddos when away but hoping they see when they get older I am doing this for myself and our family.

Hi all,

Quick question, Tectonic shift.  I couldn't get on the AE37 vaccine trial because I was too far out from adjuvant chemo.   Also, voluntary chemo? 

I did 6 rounds of xeloda following adjuvant chemo and during radiation.  Just interested, are you doing anything else?  I am trying to push the envelope with my onc.

Thanks,

Cindy (stage IIa)

Tectonic, I am in the Herceptin for Her2 "low" patients trial. I was 2+. What you just said made me happy and hopeful. Is this trial the thread is referencing the Neuvax vaccine? I really want in on this...would I need to wait until after Herceptin?

jennaJMU - here is the link to the trial (I am in the same one as techtonic shift, but at the Sibley/Washington, D.C. location):

http://clinicaltrials.gov/show/NCT00524277

This is not the Neuvax trial, it is the AE37/GP2 trial, but it is a recurrence prevention drug trial.  It was initially focused on those who are Her2+ and had received Herceptin.  You are sorted in this trial histologically, A2positives go to the GP2 arm, A2negatives go to the AE37 arm.  At some point they discovered that the lower expressors of Her2 (those who are not 0, but not considered 3+ and thus did not typically receive Herceptin) could benefit from the AE37 vaccine.  So, if you are Her2 1+ or 2+ and histologically A2negative, you can enroll in this trial.  If you are Her2 3+ you can enroll, and be sorted to either arm.  The other enrollment criteria is that you must be within 6 months of active treatment, so you would wait until the end of Herceptin.  There was some discussion of moving to the Phase III of the trial and I am not sure what that enrollment criteria will be.  When do you finish Herceptin?

crs - even though technically you are triple negative, if you expressed Her2 at 1+ or 2+ and are A2negative, within 6 months of finishing chemo or rads, you could enroll.  This trial is in very limited locations - so your travel is your own expense - the locations are listed on the trial data I linked above.  It means 7 visits in a 6 month time period, then a two year commitment to go every 6 months (two visits three weeks apart).

jenna - since you express Her2 in a lesser quantity you would be looking at enrolling in the AE37 arm - what you could do in the meantime is try to determine if you are A2negative - this is a tissue typing blood test - I have no idea of the expense, but it is like you would have for an organ transplant.  I had a good friend who worked in a transplant lab and did mine, so I know which arm I am in.  If you are A2positive then this would not be a worthwhile trial for you as it stands right now. I don't know when the Phase III will start, but they may also change the enrollment criteria and broaden it as they did midway through Phase II.  Good luck!

Tectonic shift,

Thanks for your reply.  I am stage IIIa, sorry, critical typo at the bottom of my last post! Although I actually work in the field, I have not seen Caris reports being obtained on stage III patients, and was wondering where this was being done.  Have not pushed for Herceptin, as I have cardiac issues, and had heart surgery just 4 months before being diagnosed with bc.   Just interested in the various approaches to this watchful waiting following active treatment.  Will continue to peruse for clinical trials or new treatments.

Hope all have a good day!

Cindy  (stage IIIa)

heres pic of Jade. she is half lab/border collie. she is sleeping in bed with us now. she is about four months old. took her to texaswith us. she is my 17year olds dog. will train her will i am doing my chemo here.

i am out of trial. i was on placebo. (got some bone mets) have kick ass MO 

I looked at the site and it says that while the study is ongoing, they are not recruiting new patients.  That's confusing.

I am assuming that means I don't have a chance of getting in.  ???

Anyone know if this a recent thing that they are not recruiting?