Seeking advice from Vaccine trial participants
 

I am considering one of 2 vaccine trials.
University of Washington, Arm 5, Her2 peptide vaccine plus 2000mcg Ampligen
and the Mayo Clinic MC1136, Phase 1 trial Multi-epitope Her-2/neu Peptide Vaccine with GM-CSF. I have read all the paperwork on both.
Here is what scares me. Both say if you participate and there are problems with your health caused by the trial, your insurance might not cover these problems. Wondering how you other ladies that participated in Vaccine trials feel about this? Did you contact your insurance company and tell them you were participating in a trial?

For the Mayo Clinic trial, the Vaccine includes, GM-CSF. They conduct echo's since this can effect the heart, and also they list as rare side effects Leukemia. I talked to MD Anderson and many of the trials that use GM-CSF only accept patients that have been done with Herceptin in 6 months for less. I do not qualify for any of those. Has anyone been part of a trial that used GM-CSF? If so what was your experience. I live in Illinois so Mayo is close to my home, although I have the resources to participate in the Seattle trial as well.

As you can see from my signature...I was Stage IIIc and I am 2 years and 4 months out. I really would like to be part of the advance of vaccines for all the women in my life that I love...but reading the fine print on a trial is scary. I have great overall health and a strong heart.

Can someone shed some light on your decision making process to partipate in a trial.

Re: Seeking advice from Vaccine trial participants
 

Hi there,
I'm about to get the GP2 + GM-CSF vaccine from Walter Reed. I have been waiting for this moment since I got diagnosed. The vaccine I'm getting has been given to hundreds of women and they are nearing the end of Phase 2 and will be entering Phase 3 soon. So I am not too concerned about the side effects. Actually, tomorrow I have to go in for them to test the vaccine on my thigh to see if I get a reaction. And the on Wednesday I have to stay at the hospital for 2 hours after getting the full vaccine so they can check me every 15 minutes for a reaction. From what I have read, there are a lot of vaccines that have some GM-CSF as part of their formula. So the risk of the bad effects you mention, I believe, are low. I think that the benefits outweigh the risks. Just my thought on it.

Re: Seeking advice from Vaccine trial participants
 

Hi Jill -
I am one those here who participated in the U of W Tumor Group peptide/ampligen trial.

A small arm is being launched with a higher dose of ampligen than anyone had in the phase 1 (4 different doses) trial.

I got the highest dose of ampligen and had NO side effects whatsoever. Actually felt a little less fatigued/more energy.

Good luck. If you end up coming to Seattle, let's try to meet, OK.

Re: Seeking advice from Vaccine trial participants
 

GM-CSF is also known by its brand name, Leukine. Go on www.leukine.com

Leukine (only the first dose) can give extreme fatigue side effects and even a hive at the injection site. I took Leukine instead of Neulasta (or Neupogen) as my white blood cell booster because it boosts the dendrites (as well as the other white blood cell components such as monocytes, lympocytes and the important neutrophils). The dendritic effect is what makes vaccines work and I was using it alone to try to self vaccinate during chemo. I had such extreme fatigue (only with the first dose) that I could not even move. This is extreme and at least they are making you stay 2 hrs just in case. You can read about Leukine online and you should so you know what to expect. I did not do a vaccine trial but I did do 87 doses of Leukine.

Re: Seeking advice from Vaccine trial participants
 

Hi JillaryJill

Yeah for you to be considering a vaccine!!! :)

I did the GP2 with Herceptin trial. I am thrilled that I did. Very little side effects from the GM-CSF which was given in tandem with the GP2. Just a little redness was my experience. I did not notice being tired from the vaccine. Vaccines are consider quite safe and with very few side effects if any, thus why it is such a potentially hopeful and encouraging solution to prevent this rotten cancer.

In regards to insurance, I did let my insurance know that I was participating in that trial. They did not have a problem with my participation but did say that I had something in my policy that made it acceptable. I thought that a bit strange but did not ask any more questions. As long as they gave me the green light, and we were sure about the decision from our end, I went for it. I would be a little leery to not inform them before hand. Reason being, just as you said, if something happened, I would not want to have the worry about an insurance problem on top of everything else. Though again, side effects, I believe, are likely to be very minimal.

Best of luck with your decision. :)

Re: Seeking advice from Vaccine trial participants
 

Do you have to be off treatment in order to participate in the washing UC trial? Thanks!

Re: Seeking advice from Vaccine trial participants
 

Thank you for all the input. I have one more question if anyone can answer this. I looked at my FISH for HER-2/neu gene and the score was 28.95/2.20 = 13.16 which I assume means I am a high expressor of HER-2. From what I am gathering the vaccines are more effective on the low expressers...but I am not a scientist and might not be factual here.
Any thoughts on this? Again, thank you for your help!

Re: Seeking advice from Vaccine trial participants
 

Yes, to be in the univ of wash trial you have to be Ned and off treatment.


Laurie

Re: Seeking advice from Vaccine trial participants
 

Hi JillaryJill,
I was one of the early participators in a vaccine trial in Seattle (2005). I am a high Her2 expresser. I also had GM-CSF. I had no side effects and was told 2 years later that i was a "responder".
That said, I appreciate your caution. Judging by your signature, you are NED now. You are appropriately worried about being in the minority that does experience significant side effects. On the other hand, if you can develop a lasting immunity to Her 2, you may prolong your NED for many years and perhaps prevent recurrence. Such an irresistible siren call. If you decide to move ahead; please be assured that at least in Seattle, they do monitor you very closely.
You are wise to give it much thought. i think the experiences of our members has been widely positive. God speed in your decision making.
Love and Hugs,
Kim (from CT)

Re: Seeking advice from Vaccine trial participants
 

Yes, the word has been put out that it is more effective on the lower expressors. I'm a bit skeptical, but am hoping to see the data showing this.

The posters and mid trial reports showed a positive difference between the control arm and the vaccine arm for the Her2+++. I suspect the vaccines are also effective for our group but a new, bigger market (lower expressors) has been discovered.

Ummm . . . hello . . . hand up over here! How about us high expressors?

Anyone seen the latest data?