Vaccine Trial - Page 2

eileen · 03-17-2007, 01:39 PM

Cynthia & All,

I don't think that the E75 Vaccine clinical trial at Walter Reed is the same clinical trial that is being offered here in N.Y. at Memorial Sloan or the one at the Univ. of Washington.

Does anyone know what the difference is in all of these trials?

fullofbeans · 03-19-2007, 08:34 AM

Hi all & Belinda,

I recently researched a lot about vaccination and from what I remember I also found that it was mostly for later stages (3&4). But then again it was the one I was looking for.

Regarding the above E75, I seem to remember that one of the criteria was to NOT be on Herceptin , a risk I would have been unwilling to take myself.

Remember Belinda that it is great that you are not to be eligible! and I hope that you never become eligible and remain a NED from surgery on. It is very hard when you just found out and you must still be under shock but I think it is great that you are already enquiring about further treatment, that's the spirit! so well done.

All the best for the time to come it will be hard but as my uncle told me keep your head high and back straight; a good advice. Also perhaps try to follow advice on diet there are many on this site e.g. fish oil ect..
All the best
Kx

Cynthia · 03-21-2007, 10:08 AM

While it is true that you used to be excluded from the E75 Walter Reed/Windber trial if you ever had Herceptin, it was no longer ethical for that exclusion to remain once the beneficial findings of Herceptin used in the adjuvant setting were announced a few years ago at ASCO. Now, as I understand it, an early stage person must have completed all standard treatment, including Herceptin, prior to entry into the trial. But again, please contact Windber for the specific criteria if you are interested. I just don't want people who have had Herceptin to think that they are now disqualified from this trial on that basis alone because they are not.

03-21-2007, 10:34 AM

This is further to Cynthia's post on the Windber up and coming trial. I extracted from the response I received from the Windber research team. I will add that I have no idea what HLA-A2 or 3 blood factor is, but I will try to find out. I should also mention that although I meet the preliminary guidelines, it doesn't mean that you don't meet the guidelines if you have a different pathology from mine. You will need to contact Windber for that information. See Cynthia's post for contact information. Also, I am finishing my year of herceptin at the end of August (a requirement of the trial is that you are no longer on herceptin), and it appears I will fit into the Windber timeline.

Windber is conducting a Phase II trial of two Her2 Peptides GP2 and AE37, both peptides with GM-CSF or with GM-CSF alone. GM-CSF is an already approved immune stimulator that is known to have some anti-tumor properties. The two peptides are the newer generation, coming after the earlier E75 Her2 peptide. The E75 trial is near to completion and the outcomes were announced at the 2006 San Antonio Breast Cancer Symposium. The downside of the E75 trial, is that those who did not have an HLA-A2 or 3 blood factor (determined by a blood test) could not receive anything at all and served only on observation. The newer peptides may even be more efficient, and have gone through safety testing at Walter Reed. The way the radomization works, everyone gets something that has anti-tumor properties, but you will not know whether you get the GM alone or GM plus one of the peptides.

By preliminary screening, I meet the high risk node negative criteria, by the ER/PR negativity along with Her2 positivity. Further screening, I gather, is required.

Hope this helps those of you who are considering vaccine trials and are node negative.

eileen · 03-21-2007, 10:58 AM

I think that the vaccine clinical trial given in N.Y. at Memorial Sloan & the one at Univ. of Wash. is different than the E75 trial given at Walter Reed.

The one given at Memorial is only for stage III or IV.

Does anyone know what the other differences are between these trials?

Eileen

03-21-2007, 11:19 AM

sorry, but I don't.

Cynthia · 03-21-2007, 12:48 PM

Eileen,

You ask an excellent question. I don't know the answer. It would be interesting to see if we could find a paper that addresses all of the ongoing breast cancer vaccine trials but I am not aware if one exists. Does anyone know?

Cynthia

Belinda · 03-21-2007, 08:21 PM

Hi everyone - thanks for all your replies and encouraging words, and just for the geneous sharing of info. Its one thing I love about this site.

I think this discussion will help us all. Ultimately a vaccine would be a fabulous breakthrough, not only to stop the progression of our disease, but to help our daughters and sisters.

I saw my onc before my last chemo infusion last Friday - he's keen to get hold of any articles on vaccine trials and has said he'll review and comment on them for me - I am happy to post a summary of his comments, when I get feedback from him. He's a young, inquiring kind of onc, and while he keeps up with research and immediately in front of me got on the net to find something to be able to respond to my query, he seemed unable to readily find anything on vaccine trials.

As for chemo - Day 7 of cycle 2 today, and it's slowly lifting. I hate the way chemo knocks me down physically and emotionally, and lets the door open to all my fears....

This is going to be one of my "stay positive, focus forwards" mini-projects in between crappy chemo days. It might be a slow project! But I feel like my stats are so poor and the risks so high that I need to know ahead of time all of my options, just in case. And organising 6 months of trips to the US from Australia would take some time, so better to know the viability of this option in any case.

Seems like, if this doesn't end up in a blind alley, the vaccine could be a future option beyond herceptin.

Warmest regards to all - Belindax

fullofbeans · 03-26-2007, 03:04 PM

Hi all and Cynthia,

I have put below the answer I received (FW) in Feb 2007 about W reed . I only said that you cannot be on maintenance Herceptine and receiving E75. But I agree that you can have had herceptine have finished and now take the vaccine.

"I am responding to your inquiry regarding your patient, referenced below. We would need some additional information, which is attached. Also, if she is receiving maintenance Herceptin, we have not yet included those ladies, and are not able to. A safety trial may be considered first, to be certain that the vaccine can be given safely concurrently with Herceptin. I am not able to say what the timeline is for that.

Maureen Pavlik
Joyce Murtha Breast Care Center"

I hope it helps
Kx