How many have had vaccine trial?

[michele u]

How many of us have had the vaccine trial? Which one did you get, and why did you pick that over the other? I'm trying to decide which way to go, Seattle, or windber in PA. One is DNA vaccine and the other is the E75 protein vaccine. And then the word about the new one that "might" be out sometime at md anderson. I want to get it somewhere, but how do we know which one is right for us?

Michele,
We are chosing the Washington study because it is with herceptin. My feeling is that the risk factor is lower because of that.
Al
(my understanding is that the PA study is without herceptin.)

I thought both trials were the same but different venues? I was not excepted into the Pa. one because my HLA markers were not what they were looking for. They did change the criteria to enter the trial that you can have HErceptin. This change was made in early December 2004. Please enlighten me!

[michele u]

Al, If your wife stage 4? I thought only stage 4 women could take herceptin and get the vaccine.

Michele,
That is correct however, my understanding at the time was that the PA trial DOESNOT allow concurrent herceptin use whereas the WA study does. Presuming that the hercptine use criteria was changed, just re-reading the exclusion criteria, you must be NED, which Linda is not. The WA trial is open to patients with "stable disease".
I would be more interesed in reviewing the past results. I have spoken at length with Jeff from our group who has also researched this area. Some of his findings were:

" If you are stable or NED, and off of chemotherapy, then the vaccine trials are a viable option. Though they do not have any published data, of the original group that received the vaccine 7 years ago, those that were Her2+++, and A2+ approx. 65% are still NED. Those numbers are pretty amazing" ....... "The best responders are those that are NED when they enter the trial."

Linda is now off chemo due to nerve damage and on herceptin maintenance only; therefore, we look at the vaccine as possibly being (semi)-equivelent to chemo + herceptin. The problem is that due to a lack of information it ends up being a game of "Russian Roulet" which all phase 1 and 2 trials are. We would monitor Linda constantly with monthly scans and at the hint of tumor progression, I think it fair to withdraw and go for something mainstream. I also believe that if you are at stable disease with herceptin only, there is nothing to loose and everything to gain.

The WA study is a phase 2 where dosage, dosing and safety have already been established.

I hope this clears the muddy waters somewhat.
Regards,
Al

Ronnie has just finished the trial in PA, I wonder if she has anything to add?

[Lolly]

Michele, I'm in the UW/Seattle trial, just had my first vaccine yesterday. I chose this one because:

a. Herceptin use allowed
b. Phase I-II indicates to me that safety is fairly well established
c. We live 5 hours away by car, no flying for me!

Good luck with your decision.

Love, Lolly

[Kim in DC]

I will be entering the PA trial. As of January, they are accepting herceptin users and they will be allowed to take herceptin in addition to the vaccine. I am not HLA A2 positive, I'm HLA A3 which they also accept. Plus I can drive there.

Kim

Kim, Good luck on your PA trial. Please keep us posted!
Al

I recently finished my six rounds of vaccine at Walter Reed Army Hospital (the military partner of Windber). I was eligible to go there because my husband is retired military. The experience was terrific. I had the chance to meet with the various research nurses and Dr. George Peoples, the director of the study, and to chat with him from time to time (via email) about different issues relating to the vaccine. It is so comforting to know that we have such intelligent and dedicated folks out there working on our behalf. (I was diagnosed 9/03, Her 2 +++, 4 pos. nodes, I did chemo CAF (no Herceptin), radiation and am NED. I also was HLA A2 so I met all of the criteria to get in. I never had any adverse side effects from the vaccine to speak of (just itchy legs at the injection sites which they say is a good thing). With fingers and toes tightly crossed, I am pleased to report I am doing great. I understand that a paper will be published on the results to date of the Walter Reed/Windber studies in about 3 months or so. I will let you know when I learn more about the publication of the paper.