AE37 Vaccine Trial - for recently treated high-risk patients

Kay_G

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?

SpecialK

kay - I have lymphedema but did not notice any particular increase in swelling after my injections.  I also flew to my vaccine location, so that would have confused things even more!

TectonicShift

My lymphedema started in July 2012. I still have it. It is getting a bit worse. But the vaccine trial injections didn't seem to make it get worse. But I'm quite sure I'm on the placebo. 

Momof2inME

Hi Ladies,

It took a while but I will finally fly to Baltimore May 21st to have my admit appointment and enroll in the trial. I was told there has been an addendum (change) for qualification. I will have my blood drawn for the HLA testing but they are only admitting HLA positive patients now. But I have to enroll in order to be tested. So I guess there is still a chance I won't meet requirements. And I really have no idea what HLA is? I know most of you have finished but has anyone else done it this way??

HUGS!!!!

SpecialK

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.

Momof2inME

SpecialK,

Thank you so much for the explanation. I had to read it a couple times but I get it now. Confusing stuff and I work in the science field.

SpecialK

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

 

Momof2inME

I am officially enrolled. Spent the day in Baltimore on Tuesday. Next, I will stay for a week June 10th for my first vaccine.

TectonicShift

Oh, Momof2, that's wonderful! Isn't Heather so nice??

Good luck with everything!!

Momof2inME

I met with a different nurse named Jean who was extremely nice. Heather is on vacation this week and I was told she is going to part time when she comes back. Heather and Jean will job share the coordinator position. Hope to meet her next time though...

TectonicShift

Oh, yeah, Jean is great too! All around great people there at Union Memorial. Good luck with it!

Momof2inME

Thank you for all your help and encouragement TectonicShift...

Momof2inME

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.

TectonicShift

Oh how is it going??? Do you think you are getting the vaccine? I'm sure I got placebo. Now I'm back on voluntary chemo with my new onc so I think I may have to withdraw from the trial. That's okay because maybe I can rerandomize on the phase III trial when it starts up.

cmdczc

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)

TectonicShift

Cindy,

Yes, I am back on chemo at Arlington Cancer Center in Arlington, Texas. They treat stage IIIc patients there almost as if they were stage IV, rather than as if they were stage II as most oncs do. My doc there thinks standard of care was not enough for me (finished rads June 2012) and he suggested we get a Caris report and see what it says. It said the AC+T which I had winter 2012 was unlikely to have benefitted me but Abraxane would likely benefit me. So he put me on Abraxane and also CPT-11 another chemo that Caris report suggested. Also Herceptin which he could justify to insurance because even though my main breast tumor was Her2 negative, one of my lymph node tumors was Her2 equivocal (borderline positive-negative). So I'm on Herceptin. I'm very happy with all the additional treatment but I'll be in chemo for about 2.5 more years.

At stage IIa I believe it's pretty unlikely my doc would give you any more chemo. He says standard of care is usually great for stage I and stage II. In fact I believe he himself doesn't usually even see stage II patients as he focuses on stage III and stage IV. He hands his stage I and stage II patients off to his nurse practitioner. But if you have not gotten a Caris report, I would recommend you try to do that. It's theoretical, and not foolproof, but it will tell you a lot about your tumor.

Also I recommend any breast cancer patient (except maybe true Her2 zero patients) who can find a way to get Herceptin should do it. I really really believe they are close to figuring out that Herceptin benefits Her2 negative patients as well as Her2 positive. It seems to be that breast cancer STEM CELLS over express Her2 even if the overall tumor does not. You can google that latest research. Last paper I saw on that was just about two weeks ago. It's really ongoing research.

JennaJMU

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?

5andcounting

I am triple negative. Would I even qualify for this trial?

SpecialK

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).

JennaJMU

Thanks for the info SpecialK! I finish Herceptin next July. I hope they are still accepting patients by then. I'm in PA so it's not hard to get to Baltimore or DC.

SpecialK

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!

5andcounting

Thanks Special K. I will go searching for another trial as I never expressed any her 2.

Blessings and luck to all of you:)

cmdczc

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)

SpecialK

crs319 - have you seen your actual Her2 testing?  The reason I ask is that a fair number of people are declared Her2- but still express more than 0, and that would make them eligible.  If you do not have a copy of your actual Her2 testing (rather than your path report that just says Her2-) get a copy, it may show you express at some level. 

fredntan

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 

TectonicShift

Oh oh oh!! LOVE HER!!!!!

TectonicShift

Cindy, sorry I haven't been on this thread in a while. If you want a Caris report, and you can go to Texas for about four days, make an appointment with Dr. Dicke at Arlington Cancer Center. The clinic is not too far from DFW airport. (About 15 miles which is not far in Texas distances.)

The way his consultations work are: Monday initial meeting with Dr. Dicke, Tuesday and Wednesday tests (full set of scans, labs, perhaps bone marrow bx, etc.), Thursday second meeting with doc to go over tests. At that point he will also get the ball rolling on the Caris report, which takes about 3 or 4 weeks usually. They have to arrange to get a clean sample of your tumor and send it to the Caris lab in …. Colorado? I forget where. Followup on the Caris report info can be over the phone (I think) or in person if you can come back to Texas. As for me, I just stayed there and started treatment while waiting for Caris report. I knew I wanted more treatment and at stage IIIc he agree wholeheartedly. I think I started treatment (chemo) the Monday following my consultation.

I really recommend it to any stage III patient who is interested in additional treatment. Most oncologists do only standard of care. The truth is their hands are often tied by the hospital board of directors who fear lawsuits. But there are oncs out there who feel that stage III patients need more than standard of care to stay healthy in the long run and who have set themselves up in practices where they have the autonomy to give above and beyond standard of care.

Dr. Dicke used to be head of bone marrow transplant at MDAnderson and left to start his own clinic with Dr. George Blumenschein, who was also at MDA. Dr. Blumenschein is retired but Dr. Dicke is going strong at 73. But he is not a cowboy. He only takes patients who have insurance and he gets all treatments approved by insurance before doing them. I was surprised that my Massachusetts insurance would pay for treatment down there in Texas but they do.

cmdczc

Hi TectonicShift (are you a geologist???),

Thanks for the post.  Caris Diagnostics is in Phoenix, AZ;  being in the field, I have never sent tissue on a bc case (yet), just lung, and maybe colon ca.  Spoke with my onc a few weeks ago, and he wasn't very receptive about it.   Although my tumor was large, 5.1 cm, only sentinel node (1) was positive.   He said no one in the area would give me more chemo.   Not really want to travel to TX, especially if I couldn't get the chemo here at home anyway.  Also, too far out for the AE37 trial.  This watchful waiting is soooo hard....  Will continue to scan journals, and San Antonio meeting coming up soon, too.  Thanks for "listening."

 

Fran,  Cute,cute pup!

Take care everyone!!!!

Cindy (IIIa)

AryaS

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?

Srh242

bump