More Info

This clinical trial is different from the first one in that now herceptin is being added (the first time you could not qualify if you had or were using herceptin). The unknown is how safe the vaccine and herceptin use together will be and if herceptin will boost the immune response to the vaccine. I have a very long consent form that I will try to highlight. Here goes:

The vaccine is made up of pieces of the HER2 protein and is experimental, which limits its use to research and limited number of people. This is the same vaccine they were using the first trial everyone was interested in. To be eligible you must be taking maintenance Herceptin. Anyone interested must have the blood test for Class I MHC or HLA-. This is usually done for organ transplants by most blood centers. (Other than that I have no idea what this test is). The first 9 months of the study will be conducted at UW. Your doc will then assist with follow-up. This requires an initial screening evaluation and a tetanus vaccination (to measure your immune response). The screening will include a physical, urine and blood test, chest xray, MUGA scan (minimum score not indicated), EKG. You cannot be pregnant or breastfeeding to participate. There will be six months of vaccination, checkups, blood work, urine test, etc. Another MUGA at month 9, then follow-up blood work by your doc. This vaccine also contains a small amount of GM-CSF which helps the immune systems cells grow and survive longer. Hope that helps answer some of your questions. If not, Andrea is great and very quick to respond to your requests.
Kitty

Good morning Ladies -
I am treated here in Seattle and have close contact with this trial.
This vaccine trial is a "long time coming."
When I finished my first set of chemo and rads I was on track to enter the version in which you had to NOT have any herceptin in early 2001. Liver mets as well as slow up on the trial approvals threw me out of that one.
My med onc said that I should not think about that trial any more and concentrate on getting over the hurdle that faced me. Well, I made it.
When I see him again in April we will talk about this trial. He did not want me in the other arm as we both were thinking it a bad idea get off hercptin for ANY length of time.
I have a good survivor friend who is also on track to get into the new arm (with herceptin). She and I have the same doc and are staying in close touch on this.
Any of you on this trial - please keep the board posted with what you find out - even if you are disqualified, as we ALL need to know what is happening and who is eligible.
Thanks a million!