AE37 Vaccine Trial - for recently treated high-risk patients
I want to make sure everyone here in stage 3 knows about the phase II AE37 vaccine trial that's going on right now. You can enroll in the trial if you are at least one month out from end of standard treatment (radiation or Herceptin), but not more than six months out.
Many types of breast cancer are eligible: ER+, ER-, HER2+, HER2-, male, female, node positive and high-risk node negative, up to stage 3C.
You can't be HER2-0 (HER2 zero). You have to be either HER2-1+, HER2-2+, or HER2-3+.
(Please note, only HER2-3+ is considered "HER2 positive." HER2-0, HER2-1+, and HER2-2+ are all considered "HER2 negative." You cannot be HER2-zero; you have to be at least HER2-1+ for this trial.)
You do have to travel to one of the trial sites every month for six months, and then every six months for the next two years. The first time, you have to be there for a whole week, because you have appointments Monday, Tuesday, Wednesday, and Friday-- for testing and such. After that, appointments are Monday and Wednesday, or Wednesday and Friday, once a month, for six months.
Non-military sites are in Washington (DC), Baltimore, Honolulu, Winston-Salem, Texas, and Greece.
Military sites (open to military personnel only) are in Texas, Tacoma, Bethesda, and Landstuhl Germany.
Here is the trial sheet that lists the exact locations where the trial is being offered and other specifics: http://clinicaltrials.gov/ct2/show/NCT00524277?term=ae37&rank=1
Results look very good so far: http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=125&abstractID=102964
I'm in the trial. PM me if you have questions.
Comments
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argghh whole week of dc traffic for me

how long each day? i see them monday
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My first appointment (Monday) was five hours.
I skipped the Tuesday appointment because I had had my HLA tissue typing test done at my home hospital and the trial team accepted those results.
Wednesday was two hours.
Friday was about 20 minutes.
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I just got my first injection on friday. I think I may be in the control group. I feel pretty good. No tiredness. Maybe maybe some pain in my spine. I am also four weeks out from diep. Wondering how others feel after injection. I got tiny rash on the bad breast day after injection. Same with the little mini injection. It went away. Wish I felt crappy.
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I felt nothing. Very, very faint rash at injection site two days later. But that's it. I think I am in control group too.
After second round I did feel some nausea, but the paperwork says the immune system booster that we all get (vaccine and control groups) can cause nausea.
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It looks like I am eligable, I emailed my doc at MDA (a participating facility) to see if I would work out. The travel would be a pain, but overall I think it would be great. I am only Her 2 +1 so excluded from most vaccines. We'll see how it goes.
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tectonic and fredntan - where are you guys doing the trial? Sorry if I missed this info previously. I am doing this trial also.
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I'm on trial in Baltimore
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I am flying up to D.C. monthly from Tampa. I come in a week for #5. DH was stationed at the Pentagon for many years so I still have lots of friends there and know my way around. DS lives in No. Virginia, so I have been able to see him a lot. My last trip was combined with bringing my in-laws up to the WWII Memorial - it was an awesome trip, my 87-year old FIL is a WWII vet. Your post made me laugh because it sounds like you have committed a crime, lol!
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Special k, i am at sibley in dc, did we meet last month? I have very short curly postchemo blondish hair.
Its such a small world. I got my real injection friday. I think i felt fine, also 4 weeks out from diep. -
I drive from Boston to Baltimore each month. At least I don't have to fly so it's not terrible.
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Were you there with your sister, and just signing the paperwork? If so, then yes, that was me!
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Yes that was me, too cool!
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techtonic - not any more amazing than you! That is quite a drive! I have actually enjoyed being able to come up to D.C. and see old friends - all of whom were amazingly supportive of me during diagnosis and treatment. My son is a fireman and an EMT in the emergency room so he can't always come home to visit very often - he is also a student at George Mason University - so I have really enjoyed seeing him too! I also have a new appreciation for the amount of traveling my DH has done with the military, sometimes every week - I am a little bit over being in the airport, lol!
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fredntan - yay! We met and didn't even know it! What is your schedule there? I am back up a week from tomorrow.
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I just did the first week thing. I cant remember what happens next. Suppose i have schedule around here somewhere.
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I am considering this. Is there any outcome data to date? How do we know if it will strengthen the immune system? I guess I just have more questions. I am emailing the lady in Honolulu. I've been hearing for a long time that these vaccines are going to be the new treatment for bc. Thanks so much for alerting us all to this.
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lightandwind,
I included the most recent data up in the original post. Click the link. I hope you get in the trial!
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Thanks TS! I did a little more reasearching about it. Here's a few of things I've read.
http://www.ncbi.nlm.nih.gov/pubmed/21895539
I really hope this works. It seems the Pharm has received so much scrutiny for their previous failures, it is important that they come up with something "promising". That word is certainly encouraging. They say it reduces the risk of recurrance by 46%. What a god send if it is really true. Thinking very seriously about pursuing this. Have sent my email to Honolulu.
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lightandwind - just remember that you may be sorted into the placebo group, there is no guarantee that you will get the vaccine if you participate. Also that based on your histological type you may be sorted into the GP2 arm (I am) or AE37 arm, it appears that it is pretty evenly split between the two - but that depending on the coin flip within both arms of the study you may just get the sargramostim (placebo).
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Actually it's a bit more complicated than that. At least it is now. (I think they changed the protocol a bit.)
The GP2 arm and the AE37 arm are now SHARING the control group. So it's not really a flip of a coin.
Actually you have 2/3 chance of getting the active agent (either GP2 or AE37) and 1/3 chance of getting the placebo. Which is GOOD!
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oh yeah!! I didn't really feel anything different really. maybe some bone pain? IDK. the placebo aint bad either, at least its a immune booster
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Actually I am glad to hear that the control group is not spliit, I was not aware of that, and the odds are better for getting the actual agent. I agree that the placebo is also a benefit - it is what convinced me to enroll because I figured I would derive benefit either way and it would be worth the airfare.
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how is the placebo a benefit?
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Special K, are you having any reactions after the injections?
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I think i qualify for the study. I am in Phila. Baltimore would not be bad for me. Do you or your DH have to be in the military to do this in Baltimore?
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Hi, Kay. No you do not have to be military for the Baltimore site. But you can be no more than six months out of active treatment. When did you finish active treatment? Did you do Herceptin?
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Finished herceptin in June, I better act quickly
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Okay, I'll PM you with details.
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Hi, I would love to get some information about the trial too. I will finish Herceptin in July 2013. I hope I can qualify.
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GCE - here is the link:
http://clinicaltrials.gov/show/NCT00524277
tectonic - I feel like poo after the injections but it resolves by the time I am checked 48 hours later. It has varied from bleh to fatigue. My best description is malaise...
lightandwind - here is a description of sargramostim:
Sargramostim (marketed by Genzyme under the tradename Leukine) is a recombinant granulocyte macrophage colony-stimulating factor (GM-CSF) that functions as an immunostimulator.[1]
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