New Phase II Vaccine Trial information

[Janelle]

Hi,
I contacted MD Anderson about enrolling in the E75 vaccine trial but learned that I probably won't qualify for the Phase III trial as it is not anticipated to start enrolling participants until the fall and I will likely be too far out from treatment to qualify. I learned though that they are going to be starting a phase II study on a cousin vaccine and that study has already starting enrolling patients at a couple of institutions that are participating which include Walter Reed, Brookline (a Texas military facility), Mary Crowley Cancer Center in Dallas and Wake Forest. MD Anderson believes that will start enrolling patients in May.

I spoke with Dr. Mittendorf who is the doctor who is heading up the cousin vaccine study at MD Anderson. She is looking for as many patients to enroll as possible. She is going to send me her contact info by email this afternoon and she said I could post it here and people can contact her directly.

Here is some general info on the study....(a lot of the scientific stuff was lost on me)...

1) enrollment criteria:
Her2 positive (any level of Her2 positivity is acceptable)
High risk for recurrance because of one of the following: node positive; tumor between 2cm-5cm; grade 3; lympovascular invasion, or ER or PR negative
Must have completed standard care of therapy
Must enroll between 1-6 months after primary treatment has ended (this includes herceptin treatments)
Must be NED
Must be immunolgically intact (they test for this)

2) If you are ER/PR positive, you can stay on tamoxifen if you are on it.

3) This is a Phase II study. The Phase I study had only 15 patients. In terms of adverse events, there was no horrible toxicity associated with the vaccine. There were some mild adverse events which are rated on a scale of 1-5 (a 5 is death). Of those who received the vaccine a few had grade 2 adverse events which included flu like symptoms and bone pain. There were also local adverse events which is a rash at the injection site which they like to see.

4) There are 4 arms of the study. Based on your HLA status which can be either A2 positive or A2 negative, the participatants will be divided into 2 groups. 50% oft hose who are A2 positive will receive the vaccine and the remainder will receive something called GM alone which the doctor thinks will show no benefit in this group.

If you are A2 negative, you will receive a slighly different type of vaccine or GM alone.

If you are A2 positive or A2 negative, you will be randomized into either a vaccine group which the doctor believes is promising or you will only get the GM alone treatment which sounds like they expect it to do nothing.

You must be willing to travel to one of these cancer centers every month for 6 months to receive the vaccine. <!--IBF.ATTACHMENT_289820-->

I will post Dr. Mittendorf's contact info as soon as I recieve it. Also she is going to email me some info on the old trial results and maybe some info on this "cousin" trial. If you PM me your email addresses, I will forward you the info. <!--IBF.ATTACHMENT_289815-->