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All TopicsForum: Stage III Breast Cancer → Topic: AE37 Vaccine Trial - for recently treated high-risk patients

Topic: AE37 Vaccine Trial - for recently treated high-risk patients

Forum: Stage III Breast Cancer — You are not alone. Meet others who have Stage III breast cancer.

Posted on: Sep 28, 2012 06:33PM - edited May 21, 2014 09:58AM by TectonicShift

TectonicShift wrote:

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Sep 28, 2012 08:59PM fredntan wrote:

argghh whole week of dc traffic for meFrown

how long each day? i see them monday 

Fran Dx 8/3/2011, IDC, 2cm, Stage IIIA, Grade 2, 13/17 nodes, ER+/PR+, HER2- Surgery 9/8/2011 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 3/28/2012 Breast, Lymph nodes Surgery 10/7/2012 Reconstruction (left): DIEP flap; Reconstruction (right): DIEP flap Surgery 4/2/2013 Reconstruction (left): Nipple reconstruction; Reconstruction (right): Nipple reconstruction Dx 10/2013, Stage IV, mets Hormonal Therapy
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Sep 29, 2012 04:21PM - edited Sep 29, 2012 04:21PM by TectonicShift

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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Nov 4, 2012 02:04PM fredntan wrote:

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.

Fran Dx 8/3/2011, IDC, 2cm, Stage IIIA, Grade 2, 13/17 nodes, ER+/PR+, HER2- Surgery 9/8/2011 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 3/28/2012 Breast, Lymph nodes Surgery 10/7/2012 Reconstruction (left): DIEP flap; Reconstruction (right): DIEP flap Surgery 4/2/2013 Reconstruction (left): Nipple reconstruction; Reconstruction (right): Nipple reconstruction Dx 10/2013, Stage IV, mets Hormonal Therapy
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Nov 4, 2012 06:06PM - edited Nov 4, 2012 06:07PM by TectonicShift

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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Nov 4, 2012 06:31PM MiniMacsMom wrote:

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. 

Diagnosis: 10/25/2011, IDC, 9cm, Stage IIIa, Grade 3, 4/15 nodes + Rotter's Node, ER+/P+-, HER2-, BRCA 2+
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Nov 4, 2012 06:58PM SpecialK wrote:

tectonic and fredntan - where are you guys doing the trial?  Sorry if I missed this info previously.  I am doing this trial also.

BMX w/ TE 11/1/10, ALND 12/6/10. 13 additional surgeries. TCHx6 2/17-6/2/11. Herceptin until 1/19/12. Femara 8/1/11, Arimidex 6/20/12, back to Femara 6/18/13-present. Dx 9/27/2010, DCIS, Stage 0, Grade 3 Dx 9/27/2010, IDC, Right, 2cm, Stage IIB, Grade 3, 2/14 nodes, ER+/PR+, HER2+
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Nov 4, 2012 07:00PM TectonicShift wrote:

I'm on trial in Baltimore

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Nov 4, 2012 07:18PM SpecialK wrote:

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! 

BMX w/ TE 11/1/10, ALND 12/6/10. 13 additional surgeries. TCHx6 2/17-6/2/11. Herceptin until 1/19/12. Femara 8/1/11, Arimidex 6/20/12, back to Femara 6/18/13-present. Dx 9/27/2010, DCIS, Stage 0, Grade 3 Dx 9/27/2010, IDC, Right, 2cm, Stage IIB, Grade 3, 2/14 nodes, ER+/PR+, HER2+
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Nov 4, 2012 07:27PM fredntan wrote:

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.

Fran Dx 8/3/2011, IDC, 2cm, Stage IIIA, Grade 2, 13/17 nodes, ER+/PR+, HER2- Surgery 9/8/2011 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 3/28/2012 Breast, Lymph nodes Surgery 10/7/2012 Reconstruction (left): DIEP flap; Reconstruction (right): DIEP flap Surgery 4/2/2013 Reconstruction (left): Nipple reconstruction; Reconstruction (right): Nipple reconstruction Dx 10/2013, Stage IV, mets Hormonal Therapy
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Nov 4, 2012 07:32PM - edited Nov 4, 2012 07:33PM by TectonicShift

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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Nov 4, 2012 07:33PM SpecialK wrote:

Were you there with your sister, and just signing the paperwork?  If so, then yes, that was me!

BMX w/ TE 11/1/10, ALND 12/6/10. 13 additional surgeries. TCHx6 2/17-6/2/11. Herceptin until 1/19/12. Femara 8/1/11, Arimidex 6/20/12, back to Femara 6/18/13-present. Dx 9/27/2010, DCIS, Stage 0, Grade 3 Dx 9/27/2010, IDC, Right, 2cm, Stage IIB, Grade 3, 2/14 nodes, ER+/PR+, HER2+
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Nov 4, 2012 07:34PM fredntan wrote:

Yes that was me, too cool!

Fran Dx 8/3/2011, IDC, 2cm, Stage IIIA, Grade 2, 13/17 nodes, ER+/PR+, HER2- Surgery 9/8/2011 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 3/28/2012 Breast, Lymph nodes Surgery 10/7/2012 Reconstruction (left): DIEP flap; Reconstruction (right): DIEP flap Surgery 4/2/2013 Reconstruction (left): Nipple reconstruction; Reconstruction (right): Nipple reconstruction Dx 10/2013, Stage IV, mets Hormonal Therapy
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Nov 4, 2012 07:41PM SpecialK wrote:

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! 

BMX w/ TE 11/1/10, ALND 12/6/10. 13 additional surgeries. TCHx6 2/17-6/2/11. Herceptin until 1/19/12. Femara 8/1/11, Arimidex 6/20/12, back to Femara 6/18/13-present. Dx 9/27/2010, DCIS, Stage 0, Grade 3 Dx 9/27/2010, IDC, Right, 2cm, Stage IIB, Grade 3, 2/14 nodes, ER+/PR+, HER2+
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Nov 4, 2012 07:42PM SpecialK wrote:

fredntan - yay!  We met and didn't even know it!  What is your schedule there?  I am back up a week from tomorrow.

BMX w/ TE 11/1/10, ALND 12/6/10. 13 additional surgeries. TCHx6 2/17-6/2/11. Herceptin until 1/19/12. Femara 8/1/11, Arimidex 6/20/12, back to Femara 6/18/13-present. Dx 9/27/2010, DCIS, Stage 0, Grade 3 Dx 9/27/2010, IDC, Right, 2cm, Stage IIB, Grade 3, 2/14 nodes, ER+/PR+, HER2+
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Nov 4, 2012 07:49PM fredntan wrote:

I just did the first week thing. I cant remember what happens next. Suppose i have schedule around here somewhere.

Fran Dx 8/3/2011, IDC, 2cm, Stage IIIA, Grade 2, 13/17 nodes, ER+/PR+, HER2- Surgery 9/8/2011 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 3/28/2012 Breast, Lymph nodes Surgery 10/7/2012 Reconstruction (left): DIEP flap; Reconstruction (right): DIEP flap Surgery 4/2/2013 Reconstruction (left): Nipple reconstruction; Reconstruction (right): Nipple reconstruction Dx 10/2013, Stage IV, mets Hormonal Therapy
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Nov 5, 2012 12:29AM - edited Nov 5, 2012 12:30AM by lightandwind

 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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Nov 5, 2012 05:33AM TectonicShift wrote:

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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Nov 5, 2012 12:24PM - edited Nov 5, 2012 12:25PM by lightandwind

Thanks TS! I did a little more reasearching about it. Here's a few of things I've read.

http://seekingalpha.com/article/272917-filling-an-unmet-need-a-look-at-generex-and-rxi-pharma-s-breast-cancer-vaccines

http://www.fiercevaccines.com/special-reports/10-promising-therapeutic-vaccines/ae37-10-promising-therapeutic-vaccine

http://www.news-medical.net/news/20120104/Antigen-Express-to-move-AE37-cancer-vaccine-into-larger-clinical-trials.aspx

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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Nov 5, 2012 12:35PM - edited Nov 5, 2012 12:40PM by SpecialK

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).

BMX w/ TE 11/1/10, ALND 12/6/10. 13 additional surgeries. TCHx6 2/17-6/2/11. Herceptin until 1/19/12. Femara 8/1/11, Arimidex 6/20/12, back to Femara 6/18/13-present. Dx 9/27/2010, DCIS, Stage 0, Grade 3 Dx 9/27/2010, IDC, Right, 2cm, Stage IIB, Grade 3, 2/14 nodes, ER+/PR+, HER2+
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Nov 5, 2012 03:37PM TectonicShift wrote:

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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Nov 5, 2012 03:50PM fredntan wrote:

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

Fran Dx 8/3/2011, IDC, 2cm, Stage IIIA, Grade 2, 13/17 nodes, ER+/PR+, HER2- Surgery 9/8/2011 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 3/28/2012 Breast, Lymph nodes Surgery 10/7/2012 Reconstruction (left): DIEP flap; Reconstruction (right): DIEP flap Surgery 4/2/2013 Reconstruction (left): Nipple reconstruction; Reconstruction (right): Nipple reconstruction Dx 10/2013, Stage IV, mets Hormonal Therapy
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Nov 5, 2012 04:38PM SpecialK wrote:

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. 

BMX w/ TE 11/1/10, ALND 12/6/10. 13 additional surgeries. TCHx6 2/17-6/2/11. Herceptin until 1/19/12. Femara 8/1/11, Arimidex 6/20/12, back to Femara 6/18/13-present. Dx 9/27/2010, DCIS, Stage 0, Grade 3 Dx 9/27/2010, IDC, Right, 2cm, Stage IIB, Grade 3, 2/14 nodes, ER+/PR+, HER2+
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Nov 5, 2012 06:00PM lightandwind wrote:

how is the placebo a benefit?

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Nov 5, 2012 06:43PM TectonicShift wrote:

Special K, are you having any reactions after the injections?

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Nov 5, 2012 07:05PM Kay_G wrote:

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?

Well that is a pie crust promise, easily made, easily broken. Mary Poppins
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Nov 5, 2012 07:12PM - edited Nov 5, 2012 07:13PM by TectonicShift

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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Nov 5, 2012 07:41PM Kay_G wrote:

Finished herceptin in June, I better act quickly

Well that is a pie crust promise, easily made, easily broken. Mary Poppins
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Nov 5, 2012 08:07PM TectonicShift wrote:

Okay, I'll PM you with details.

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Nov 5, 2012 08:29PM GCE wrote:

Hi, I would love to get some information about the trial too. I will finish Herceptin in July 2013. I hope I can qualify.

Dx 5/30/2012, IDC, 3cm, Stage IIIC, Grade 3, 12/19 nodes, ER+/PR+, HER2+
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Nov 5, 2012 09:26PM SpecialK wrote:

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] 

BMX w/ TE 11/1/10, ALND 12/6/10. 13 additional surgeries. TCHx6 2/17-6/2/11. Herceptin until 1/19/12. Femara 8/1/11, Arimidex 6/20/12, back to Femara 6/18/13-present. Dx 9/27/2010, DCIS, Stage 0, Grade 3 Dx 9/27/2010, IDC, Right, 2cm, Stage IIB, Grade 3, 2/14 nodes, ER+/PR+, HER2+

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