Ampligen w/Vaccine Therapy for Stage II-IV HER2+ BC

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Hi all!  I feel blessed and honored that I was invited and recently participated in an exciting HER2 breast cancer vaccine w/ adjuvent Ampligen clinical trial at University of Washinginton (sponsored by Fred Hutchinson Cancer Research Center).  Her2 Breast Cancer Vaccines have always been an interest of mine ever since my diagnosis in July 2007, but I was always excluded from participating as I was stage 2, and the vaccines were only being tested on stage 4 patients.  Anyway, they are now including stage 2 and 3 Her2+ survivors, too, including those who are years post treatment!

The results of my trial will be available to me in about a month, to let me know whether my immune system generated a response to the particular dose of Ampligen I was randomly assigned to along with the Her2 Vaccine.  I am hoping my immune system generated a response, but even more, I am just happy and excited to have been able to participate and be a part of something that might help ladies down the road, much in the way that ladies who came before me, especially those who paved the way in trials of Herceptin, helped me!

 "This randomized phase I/II trial studies the side effects and best dose of Ampligen when given together with vaccine therapy and sargramostim (GM-CSF) to see how well it works in treating patients with stage II-IV human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Vaccines made from synthetic HER2/neu peptides may help the body build an effective immune response to kill tumor cells that express HER-2/neu. Our group has developed vaccines against the HER2 protein that create immune responses and in this study we are researching different ways that we may be able to make that immune response even better. Adjuvants are one way to help vaccines produce stronger immune responses. Our group has typically used the adjuvant GM-CSF and in this study we would like to look at another adjuvant called Ampligen. Giving vaccine therapy together with Ampligen and/or GM-CSF may be an effective treatment for breast cancer."

If any of you are interested in more info about this ongoing clinical trial in Seattle, WA, here are the details and link:

Ampligen w/Vaccine Therapy for Stage II-IV HER2-Positive Breast Cancer
Phase I-II Study of HER2 Vaccination with poly(I) Poly(C12U) (Ampligen®) as an Adjuvant in Optimally Treated Breast Cancer Patients

http://www.seattlecca.org/clinical-trials/breastcancer-NCT01355393.cfm

http://clinicaltrials.gov/show/NCT01355393

Comments

  • LindaKR
    LindaKR Member Posts: 1,577
    edited October 2012

    Did you get any results yet - I'm really interested in participating and just sent an email.  It sounds pretting amazing!

  • babysandpiper
    babysandpiper Member Posts: 13
    edited February 2013

    Hi Linda,  I am sorry I didn't see your mail until last night, or this post until this morning.  I emailed you last night that although they had said preliminary results would be available around last May, they have delayed releasing anything at all, and keep telling me they will mail it (but they still haven't).  Thanks to your information, it sounds like they added a new arm to the study with a higher dose of Ampligen.  I hope all is going well for you!

  • Anonymous
    Anonymous Member Posts: 1,376
    edited July 2013

    Hello babysandpiper-In your post you mentioned "The results of my trial will be available to me in about a month, to let me know whether my immune system generated a response to the particular dose of Ampligen I was randomly assigned to along with the Her2 Vaccine". Any updates? Would you be kind to share. thanks

  • babysandpiper
    babysandpiper Member Posts: 13
    edited July 2013

    Hi ampvac,



    It took several months to get my preliminary results as they needed to add an additional arm with a higher dosing of Ampligen to the study. My dose had the least amount of Ampligen, and the preliminary results showed it did not generate an immune response. Hoping the higher doses have success! I would highly recommend participating in the trial if it is still open!

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