Confused About Vaccine

[eileen]

I had an interview this past week with Dr. Teresa Gilewski at Memorial Sloan Kettering regarding their Phase 1Xenogeneic HER2/neu DNA vaccine clinical trial. Only about 12 people will take place in the trial & so far their are no recruits although the doctor said they were waiting for some people to finish their treatment.

The doctor told me that I qualify for the vaccine; that I might have flu-like side effects; thyroid problems (but not likely, unless I had previous thyroid problems); that the vaccine has not been tested on humans, only on rats. I will be given a total of 5 injections over 13 weeks & followed closely with scans (MUGA, CAT & BONE scans) & blood tests.

I want to do everything to prevent my cancer from coming back, so far NED (diagnosed 10/04; stage III; lumpectomy with 7 positive nodes; ER+; HER2+; chemo & herceptin) but I'm very hesitant about being in a Phase 1 trial & I couldn't get a straight answer from the doctor as to when Phase II will begin or even if there will be a phase II.

I'm also really confused about the differences between the other clinical trials going on at other facilities...the one at Univ. of Washington; Univ. of Pa.; Walter Reed & Bavarian Nordic (a new one). I think that Dr. Gilewski did say that this trial was similar to the one at the Univ. of Wash., but not quite the same.

I'm really having a problem sorting this out & would like to talk to somebody about this before I jump into it but I'm not sure who that would be.

Eileen

[Lolly]

Hi Eileen,
I was in the UW/Seattle "Phase II Study of a HER-2/neu Intracellular Domain (ICD) Peptide-Based Vaccine" in Spring 2005...
I found the trial coordinator very helpful about answering questions regarding the different studies available at UW, and was even sent the Consent Form when I requested it prior to actually enrolling in the study. Asking for the Consent Form was a tip my oncology nurse gave me, and it proved valuable as the form contains all the information about the trial drug that the study is mandated by law to provide to volunteers so they are fully informed. It wouldn't hurt to ask for the consent form for Xenogeneic HER2/neu DNA vaccine from MSK. Also, check out the UW/Seattle clinical trials and don't hesitate to contact Patty Fintak(contact info available on their clinical trials page)with questions about the differences between their various vaccines...
I'm sorry I don't have the answers for you, but I really don't understand the differences either! Maybe one of our "propeller heads" will post with some comments?

Here's a link to the UW Clinical Trials page if you haven't visited it already:
http://depts.washington.edu/tumorvac/trials.php