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Old 09-24-2011, 07:51 PM   #1
Elizabethtx
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Phase II vaccine trial...looking for info

My onc is the principal investigator for the phase II trial of GP2 or AE 37 in San Antonio. I know there are 16 sites across the US participating in the trial. This trial is from Col. Peoples and the Cancer Vaccine Development Program with the military.

My initial research tells me it is designed to determine ability to prevent Her 2 reoccurrence, immune response and safety in dosing. Has anyone out there participated in a vaccine trial? If so, are you currently in this one? What kind of side effects did you experience?

I feel led to participate for the sake of research into a cure, but want to hear your thoughts!

Thanks for any insights you may have!
Elizabeth
__________________
Diagnosed: Feb 2010 @ 46 yrs old
Invasive Ductual Carcinoma, left
2/28/10 Bilateral Mastectomy (tissue saving for future reconstruction)
3.2 cm 2/18 +lymph nodes
Stage 2b; E+/P+/Her2 +++
Nottingham score grade 2
Ki67 30%
3/2010 A/C 4 DD/2wks
5/2010 Herceptin/Taxotere 4D/3wks
8/2010 Herceptin until May 2011
Tamoxifin 20mg
9/2010 RAD 34 treatments
Pet scan Aug 2010 clear
Port removed July 2011
Bone scan, chest MRI 12/11 clear
Vaccine trial began Oct 2011








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Old 10-03-2011, 10:10 AM   #2
Jackie07
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Re: Phase II vaccine trial...looking for info

Elizabeth,

My oncologist has been discouraging me from participating in clinical trials possibly due to my decreased heart function after chemotherapy.

Below is an abstract of the Phase I trial report. It looks promising. Do keep us updated on your participation in this trial:

Expert Rev Vaccines. 2011 Feb;10(2):201-10.
Comparison of different HER2/neu vaccines in adjuvant breast cancer trials: implications for dosing of peptide vaccines.

Benavides LC, Sears AK, Gates JD, Clifton GT, Clive KS, Carmichael MG, Holmes JP, Mittendorf EA, Ponniah S, Peoples GE.
Source

Department of Surgery, General Surgery Service, Brooke Army Medical Center, 3851 Roger Brooke Drive, Ft. Sam, Houston, TX 78234, USA.

Abstract

We have performed multiple adjuvant clinical trials using immunogenic peptides from the HER2/neu protein (AE37/E75/GP2) plus (GM-CSF) given intradermally to breast cancer patients. Four trials were performed with similar dose-escalation design with increasing doses of peptide (AE37/E75/GP2) and varying amounts of GM-CSF. Dose reductions (DRs) were made for significant local and/or systemic toxicity by decreasing GM-CSF for subsequent inoculations. Ex vivo and in vivo immunologic responses were used to compare groups. Of 132 patients, 39 required DR (30 for robust local reactions [DR-L]). DR patients, particularly DR-L, had greater immune responses both ex vivo and in vivo. Postvaccine delayed-type hypersensitivity in DR-L patients compared with all others was larger for E75 (p = 0.001), AE37 (p = 0.077) and GP2 (p = 0.076). All three peptide vaccines were safe and well-tolerated. These findings have led to a clinically relevant optimal vaccine dosing strategy, which may be applicable to other peptide-based cancer vaccines.
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http://www.kevinmd.com/blog/2011/06/doctors-letter-patient-newly-diagnosed-cancer.html
http://www.asco.org/ASCOv2/MultiMedi...=114&trackID=2

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Last edited by Jackie07; 10-03-2011 at 12:41 PM..
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Old 10-03-2011, 08:08 PM   #3
Elizabethtx
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Re: Phase II vaccine trial...looking for info

Thanks Jackie for the links. I will do a little more research. I have decided to participate and am awaiting the FISH results on my tumor. For some reason it was not done at the time of the MX. I will have blood work done then be randomized into an arm of the trial. I will have to switch oncologists which makes me a bit nervous, but I think it will be fine. I'll keep everyone up to date on how it goes! Wish me luck!
__________________
Diagnosed: Feb 2010 @ 46 yrs old
Invasive Ductual Carcinoma, left
2/28/10 Bilateral Mastectomy (tissue saving for future reconstruction)
3.2 cm 2/18 +lymph nodes
Stage 2b; E+/P+/Her2 +++
Nottingham score grade 2
Ki67 30%
3/2010 A/C 4 DD/2wks
5/2010 Herceptin/Taxotere 4D/3wks
8/2010 Herceptin until May 2011
Tamoxifin 20mg
9/2010 RAD 34 treatments
Pet scan Aug 2010 clear
Port removed July 2011
Bone scan, chest MRI 12/11 clear
Vaccine trial began Oct 2011








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Old 10-05-2011, 07:39 PM   #4
'lizbeth
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Re: Phase II vaccine trial...looking for info

Oh I just saw the post. Im getting ready to fly back to San Antonio in the next 4 to 6 weeks for my booster in this clinical trial. I can't say enough good things about the Clinical trial nurse, Karen. She is just absolutely wonderful. An absolute joy to work with. I am in the GP2 arm, and I thought you might have already heard from my trial buddy in the AE37 arm.

Participate! The side effects are not like chemo. You'll have some raised red bumps likely at the injection sites, maybe flu like symptoms, headaches, itching - but nothing a bit of tylenol cant relieve. We both agreed that we physically felt better after participating, and we are helping progress treatments for breast cancer. Its all good. Since you are already in San Antonio it shouldn't be a big time commitment. Karen can explain it all - have you contacted her yet?

I'd be happy to answer your questions,

'lizbeth
__________________
Diagnosed 2007
Stage IIb Invasive Ductal Carcinoma, Pagets, 3 of 15 positive nodes

Traditional Treatment: Mastectomy and Axillary Node Dissection followed by Taxotere, 6 treatments and 1 year of Herceptin, no radiation
Former Chemo Ninja "Takizi Zukuchiri"

Additional treatments:
GP2 vaccine, San Antonio Med Ctr
Prescriptive Exercise for Cancer Patients
ENERGY Study, UCSD La Jolla

Reconstruction: TRAM flap, partial loss, Revision

The content of my posts are meant for informational purposes only. The medical information is intended for general information only and should not be used in any way to diagnose, treat, cure, or prevent disease
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Old 10-11-2011, 06:43 PM   #5
Estelle
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Re: Phase II vaccine trial...looking for info

Hi all,
I am in the Johns Hopkins vaccine trial, and just finished by fourth (booster) set of shots -- yoo-hoo!! Done with shots, and a few more weeks of herceptin to go (and more more set of peptides!!) Just celebrating that I made it through w/out any issues!
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Estelle
DX 1/09
two tumors; .7 cm and 1.0 cm, same duct
lumpectomy 2/09
10 positive nodes; scans show no further metastasis, Stage IIIc
AC completed 5/09
Tykerb/Taxol (trial) 6/09, terminated from trial (due to bad reaction to Tykerb) 8/09; switched to Herceptin/Taxol
Taxol finished 10/09
Bilateral mastectomy 11/09
Radiation 12/09 to 1/10
Herceptin finished 7/10
NED
Start Vaccine Trial at Hopkins 2/11
Finished Vaccine Trial 11/11
Continue NED
Port Out 11/11
DEIP Flap 4/17)
8 Years NED 2/17
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Old 10-12-2011, 08:55 PM   #6
candlegranny
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Re: Phase II vaccine trial...looking for info

Esheelle, i called them today. my husband and i will go up there 1st of novemeber to meet with Dr emens when she returns from europe. I dont like shots or needles and still have my port so herceptin and blood work can be done thru that. can you message me about all the biopsy they do to your skin and all the shots you get.. i know there is 12 is that every month or jsut the first time> do you live in baltimore? just curious.
I have a cancer policy with AFLAC found out from my agent today they will pay my airfair ( from Louisville ky to baltimore) and my hotel and pay me for my treatments too. AFLAC was a life saver for us durin the last 2 yrs. sorry just had to talk about that blessing.
__________________
Mammogram Sep 21, 2009 everything good and clear
DX jan 19,2010 Invasive Ductal Carcinoma, Grade 2 Age 56
modified radical masectomy on LEFT side 29 Jan 2010
2.7 cm 18/31 nodes
mets to just above collar bone ( 2 nodes showed in PET)
ER- PR - / Her2 +++ (IHC) Stage 111 C
ki-67 60% nottingham score 7
A/C chemo mar 22,2010 DD
herceptin & taxotere DD june 1,2010
finished taxotere july 12, 2010
finished herceptin 16 May 2011
PET Scan 9 Aug 10, cancer in neck is gone! NED
33 Rads completed 1 Oct 2010
PET/CT Scan 6 Jan 2011 NED
PET/CT Scan 3 Aug 2011
MUGA 59% 3/22/10 -63% 9/23/10 - 51% 1/4/11 - 55% 2/17/11 - 50% 8/3/11
26 Aug 2011 NED
20 Feb 2012 NED
5 Mar 2012 PORT OUT
12 July 2012 DIEP breast reconstruction
23 Aug 2012 NED
15 Nov 2012 new breast tweeked and natural breast uplifted and implant added
17 Feb 2013 NED
27 mar 2013 lipo suction to add fat cells to new breast in hopes for needed adjustment.


"Don't spend your time worrying about when or how you are going to die, spend your time figuring out how you are going to live today". ~Elizabeth Edwards.
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Old 02-01-2012, 10:51 PM   #7
bbradley9
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Re: Phase II vaccine trial...looking for info

Hi all, i have have some sleepless nights about doing the trial, but after joining this sight and reading the post it sounds very promising, i prayed and ask for some sort of guideance and it looks like the lord has answered my prayer, i will call in the morning to give the ok for the trial. It's great to hear such good news about the trial. Thanks
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Old 02-04-2012, 02:35 PM   #8
'lizbeth
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Re: Phase II vaccine trial...looking for info

So glad to have you join us - both the Her2support and the vaccine trial groups.

Which vaccine trial and which location are you signing up for?
__________________
Diagnosed 2007
Stage IIb Invasive Ductal Carcinoma, Pagets, 3 of 15 positive nodes

Traditional Treatment: Mastectomy and Axillary Node Dissection followed by Taxotere, 6 treatments and 1 year of Herceptin, no radiation
Former Chemo Ninja "Takizi Zukuchiri"

Additional treatments:
GP2 vaccine, San Antonio Med Ctr
Prescriptive Exercise for Cancer Patients
ENERGY Study, UCSD La Jolla

Reconstruction: TRAM flap, partial loss, Revision

The content of my posts are meant for informational purposes only. The medical information is intended for general information only and should not be used in any way to diagnose, treat, cure, or prevent disease
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Old 04-11-2012, 11:00 AM   #9
teresamd0906
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Re: Phase II vaccine trial...looking for info

I just received notice that the vaccine trial here in Houston at MD Anderson is now open again due to additional funding. I would like to hear from anyone that is/has done this - can you give me some insight as to what I should expect if I do this? Will I have to stop my daily oral chemo pill? Will it be of any benefit to helping prevent a recurrence for me? I want to do my part to help with research and at the same time help myself. Thanks everyone - oh and I have AFLAC and would love to hear what they pay for.
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Old 04-11-2012, 01:31 PM   #10
teresamd0906
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Re: Phase II vaccine trial...looking for info

Hi Candlegranny! I have AFLAC also - it has been so awesome on paying for EVERYTHING the past year. What all did it pay for with the Breast Cancer Vaccine Trial?

Thanks!
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Old 04-11-2012, 08:29 PM   #11
candlegranny
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Re: Phase II vaccine trial...looking for info

I didnt do the trial in baltimore..but my agent told me it would pay transportation even airfare and hotel too. i love AFLAC. I am getting ready for reconstruction..it pays some of that too
__________________
Mammogram Sep 21, 2009 everything good and clear
DX jan 19,2010 Invasive Ductal Carcinoma, Grade 2 Age 56
modified radical masectomy on LEFT side 29 Jan 2010
2.7 cm 18/31 nodes
mets to just above collar bone ( 2 nodes showed in PET)
ER- PR - / Her2 +++ (IHC) Stage 111 C
ki-67 60% nottingham score 7
A/C chemo mar 22,2010 DD
herceptin & taxotere DD june 1,2010
finished taxotere july 12, 2010
finished herceptin 16 May 2011
PET Scan 9 Aug 10, cancer in neck is gone! NED
33 Rads completed 1 Oct 2010
PET/CT Scan 6 Jan 2011 NED
PET/CT Scan 3 Aug 2011
MUGA 59% 3/22/10 -63% 9/23/10 - 51% 1/4/11 - 55% 2/17/11 - 50% 8/3/11
26 Aug 2011 NED
20 Feb 2012 NED
5 Mar 2012 PORT OUT
12 July 2012 DIEP breast reconstruction
23 Aug 2012 NED
15 Nov 2012 new breast tweeked and natural breast uplifted and implant added
17 Feb 2013 NED
27 mar 2013 lipo suction to add fat cells to new breast in hopes for needed adjustment.


"Don't spend your time worrying about when or how you are going to die, spend your time figuring out how you are going to live today". ~Elizabeth Edwards.
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