To Michele U regarding vaccine trial

Michele,

I would like to participate in the UW vaccine trial for stage 3. But the condition that one should be menopausal to be eligible is really bothering me. I am 37 and my periods are back after chemo. I know that you got your overies removed. But did they really check your menopausal condition(with blood test) as part of their screening? I am not sure why this is the criteria only for stage 3 and not for stage4 non DNA or peptide based vaccine. Please shed some light on this.

Thanks,
Julie

[michele u]

Julie,
They did not do any blood work for that on me. Since i had my ovaries out they didn't have to. I think the reason for the menapausal question is that they do not know what this would do to a pregnancy. Are you done having children? Are you er/pr negative? I'm not for sure what their requirements for stopping periods while doing the vaccines. I will email Dr. Disis and ask her for you

[Rozebud]

Julie - I can answer that question as I have been going back and forth with Patty on it. Yes, they do require a LH/FSH test. I asked what the problem was and she said that the vaccine can be passed through the placenta and they want to make sure you can't have more children. Right now I'm on zoladex shots for 5 years (I'm 35), and my assumption is that if I pass this test, I qualify for the vaccine. Even though theoretically I could get my periods back. Not sure I want to get my ovaries out just for the vaccine....I may consider doing it for my breast cancer (I'm slightly PR+). I mentally know I need to be done with kids, but it still makes me sad....ovary removal just seems so permanent, even though I know more kids are not in the cards for me. Hope that helps!

Actually, here is her exact response (I asked why it was not required to be past childbearing to get herceptin, but you had to for the vaccine):
"The vaccine is not Herceptin based, rather it is a HER-2 (neu) plasmid-based DNA vaccine. Not being of childbearing ability is an eligibility criterion because we, in addition to the FDA, do not want patients to become pregnant post-vaccine. All subjects must no longer be able to bear children because HER2 is overexpressed in normal fetus tissues. Therefore, induction of long-term immunity to overexpressed HER2 could affect the viability of a future fetus."

Michele and Rose,

Thanks for the replies. I have two kids and am not planning to have anymore kids. I am er-/pr- only her2+++.
So if I take temporary ovary suppression drugs like zoladex or Lupron during the vaccination period, will I be eligible to participate? Also If I do permanat contraceptive methods like sterilization (tubal ligation) will I be eligible. I can go to the extent of removing ovaries for vaccination but am not sure about the implications of that. I am sorry to ask you all these questions but please let me know if you know anything.

Thanks again,
Julie

[Lolly]

Julie, I am in the Her2 vaccine trial which involves a HER2-peptide based vaccine, and the consent form I signed gave explicit warnings about the possibility of miscarriage or severe birth defects. It goes on to say that ..."if you are a man or a woman who is able to have children, you should be done with child-bearing and must agree to use an adequate form of birth control during study participation. Women should continue adequate birth control until they are menopausal...If you are a woman who is able to have children, you will be given a pregnancy test before you begin the study to make sure that you are not pregnant..."

Hope this helps...

<3,
Lolly

[michele u]

I emailed Dr. Disis and asked her about the pregancy issue. she said it really depends on what trial you are entering. All the vaccine trials have different enrollment requirments. She said the best thing to do is email them or call them. Patty's email is paf3@washington.edu and her phone number is 206-543-6620

Michele,

Thanks for emailing Dr. Disis. I will call Patty for more details.

thanks,
Julie

[Rozebud]

I agree. There are some pretty serious implications to removing ovaries (e.g. oesteoperosis) that early menopause causes. Maybe your husband could take care of it :) ?

I'd be very interested in what they tell you....as I'm interested in the exact same trial.

Rozebud,

I talked to Patty and according to her if tubes are tied one will be eligible for the DNA vaccine eventhogh they are not menopausal. That is a good news.

Julie