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

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.

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!

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

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!

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.

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

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?

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.

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!

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