Question for Lolly (or others) about vaccine trial

hi Lolly--
When you have spoken with the medical staff about this trial, have you heard how long they expect it to run? Any idea of when a vaccine will be clinically available?

My Her-2 cancer has not metastisized but I started with a large tumor and am now going through neoadjuvant chemo (Herceptin/Carboplatin/Taxol). I am trying to decide what surgery option to take, and the vaccine interests me because it may have an affect on what I decide to do with my healthy breast when I have surgery.

thanks!
Val

[Lolly]

Hi Val; this particular study will be accruing a total of 20 volunteers, and I'm #8. One of the criteria is that you need be Stage 4, which thank heaven's you are not, but you may qualify for the other vaccine, which allows Stage 3-4. You have to be off all chemo, steriods and Herceptin for one month. I don't know where they are in terms of enrollment for it, but you should feel free to contact Patricia Fintak and she may be able to give you an idea. Her contact number is contained in my previous post sub-titled "Report to the Troops". I do know that Dr. Salazar said that as of now they have every expectation on being able to continue designing new studies in the future, so if you don't get into either of these there will most likely be something you may qualify for down the road. I don't know when they hope to have the vaccine available for clinical use, but if we use Herceptin as a guideline, it was I think 9 years from Phase I Trials until FDA approval for clinical use in Stage 4 disease.

Good luck with your surgery!

Love, Lolly

Thanks Lolly...The nine year answer was what I was looking for...but I was hoping for a shorter time period! I am still in the process of treatment and I didn't know how long trials take from start to clinical use. I won't be eligible for a trial like that until the end of the year when I am done with everything. Nine years is too long for me to use the possibility of the vaccine in my decision-making process about surgery. I was thinking that if the vaccine were available next year, I may be able to get away with removing only my cancerous breast. I am currently trying to decide what to do about the healthy one.

Although who knows about these timelines...from what I gather reading this board, I am not receiving Herceptin in a standard practice sort of way...however a vaccine trial is a bit different than using herceptin for neoadjuvant chemo treatment. With the vaccine I am sure they will be examining the longer-term results/effects. I hope it all goes well for you. Please keep posting about everything you experience with this trial :-)

Val

[Lolly]

Val, you can be sure I will keep the board posted. As to my "guess-timate" about if/when the vaccine will be available for clinical use, please remember it is only MY GUESS, I don't have any statement from anyone at UW to back that up. It could be longer, it could be never. Don't mean to sound like a wet blanket, but these are early days yet, and this is only a Phase I-II trial, which means they're still determining safety, so stay tuned.

Love, Lolly

[Kim in DC]

Hi Val,

I am trying to participate in The Vaccine trial in PA at Windber. This is at Phase Ib. If you google "Dr Peoples breast cancer Vaccine" you should be able to pull up a lot of articles on the trial when it was reported to the American College of Surgeons in Oct2003

Like you I had neoadjuvant therapy. I Just had my masectomy on Jan. 3. Now I am on adjuvant therapy. I don't plan to be finished with chemo and radiation until June.

For the PA trial, they will accept you at stage 3 or 4 but you have to be NED. You must test for HLA A2 or HLA A3 protein. You have to be finished with all treatment except Herceptin for 2 months. As of 1/11/05 they had 64 ladies enrolled and the goal for this phase is 120.

If you would like more information, contact Maureen Pavlik at 866-253-4703