Vaccine trial update

Elizabethtx · 10-24-2011, 08:27 PM

Just a little update from me. I have been out of the loop for awhile. Last post I was asking questions about a Her 2 vaccine trial. Thank you to everyone who responded or sent a pm. It means the world to me to be able to get advice from you!

I signed the consents, did the preliminary blood work last week. Today I went in for the skin test where they inject a small amount of the peptides in order to watch for reaction. I did great! No reaction at all so far. Three injections on the leg. On wed I return for the first set of full injections. This is the AE 37, GP27 with GM-CSF. Of course it is a blind study so i have no idea what I am really getting. If you interested in updates, send me a note and I will tell you how it goes!

StephN · 10-24-2011, 09:53 PM

Great to hear you have joined the Vaccine Trial Club here. It will be very interesting to see how our repective vaccine trials fare.

Good luck with the real thing. Keep us posted on how you feel, etc.

Jackie07 · 10-24-2011, 10:00 PM

It's good to hear from you. Thanks for sharing. Please keep us posted.

Pray · 10-24-2011, 10:05 PM

Elizabeth,

Your pm box is full. I would love to hear up dates on how you are doing. We have similar dx's. When you have a chance please add me on!

I sure hope you get the real thing! Gods blessings to you.

Your Friend,

Nancy

'lizbeth · 11-05-2011, 10:04 AM

Hey, is Karen your nurse? She is awesome. I'm headed out to San Antonio for my booster in just a few weeks. I am in the other arm, the GP II myself.

Glad you joined us vacciners!

Becky · 11-05-2011, 02:12 PM

Dear Elizabeth

Do you know if you will be getting the GM-CSF (brand name Leukine) even if you do not get the vaccine active? I believe that you will as the GM-CSF has some "self vaccination" properties in its own right and if they didn't, the researchers really couldn't attribute a good result from the vaccine alone.

GM-CSF is a white blood cell booster. It is like Neupogen/Neulasta (G-CSF) but has some unique and interesting properties that the G-CSF does not. Neulasta types boost your white count but only boost the neutrophils. Neutrophils are the body's first defense against infection which is why the onc's like it. Also, it works relatively quickly in boosting the neutrophils.

GM-CSF (Leukine) boosts all white blood cell types - neutrophils, monocytes, lymphocytes and most importantly - the dendrites (the white blood cell component that assists in the vaccination - aka life long immunity process). As a wbc booster during chemo, it can take alittle longer for the neutrophils to return especially after the first round of chemo - other than that, it works just as fast in subsequent rounds.

In a sense, Leukine can self vaccinate if given before, during and after the chemo process - when there is still cancer in the body. Leukine boosts the dendrites that identify the cancer, rush to the lymph nodes where the Bcells encode the invader and produce the killer T cells against the cancer (or anything you have been sick from before or vaccinated against - ie: you never catch the same cold twice and you don't get polio if you have been vaccinated).

One reason they are giving it in vaccine trials is to boost the dendritic effect so that the dendrites find the vaccine component and then those dendrites rush to the nodes and start the process. But, as you can see, if you still have a dormant cancer cell in the body, there is a chance that the Leukine can do this all by itself but not as effectively as if the vaccine active is there because at this point, if there is cancer in your body, it is like finding a needle in a haystack and the dendrites have to find that cell or two. None the less, if you only get the Leukine, it is not a waste as something good can come from just that.

I know alot about Leukine because I am one of the oddballs who insisted and received Leukine injections upon diagnosis of my cancer and used the drug as my WBC booster instead of Neulasta. I continued Leukine after my last chemo( 7 injections). In all, I had 87 injections. I did not have problems with delay of any chemo cycles although I was told this could happen - I took my chances and won on that.

Be aware that many people have problems with the first Leukine injection (but only the first). I had problems but continued with 86 other problem free injections. The first shot can cause incredible fatigue about one hour afterwards. Hopefully they keep everyone in the clinic for awhile just to make sure no one has reactions. The fatigue can be so great that you cannot drive. If this happens to you, I guarantee you will be frightened but it is a side effect that can happen (but it will never happen again as subsequent shots are like nothing and if it happens, you will feel fine the next day).

Like Neulasta, you will get the bone pain because your bone marrow is being stimulated to make white blood cells. I do not know if you had Neupogen or Neulasta during chemo but if you did, you will find the same symptoms as that with Leukine. And you will only get the one shot (I am guessing - one with each "vaccine" shot) - I had to take 10 shots per cycle of chemo (one per day starting 24 hrs after chemo). So if just one shot, the symptoms of bone pain will be gone in 24 hrs and viola!

I had the pleasure once to have dinner with the fine doctors at the Univ of WA vaccine programs. I mentioned the GM-CSF (Leukine) shots I had and they told me at that time that that was one of the smartest things I ever did for myself (at the time, Herceptin was not available and I had positive nodes so I was quite frantic - even though later I did get late Herceptin alone after chemo, rads etc were well over with).

Anyway, let us know how it goes and if you get the GM-CSF regardless.

Hugs to you

PS - you can read more about Leukine at www.leukine.com

Ellie F · 11-05-2011, 02:46 PM

Becky
Thanks for such a comprehensive explanation especially as I am still interested in vaccine trials.
Ellie

Sandra in GA · 11-05-2011, 04:53 PM

'lizbeth and I are in the same tiral as Elizabeth/tx. The persuading reason I decided to do the trial was because of the inclusion of the GM-CSF. Everyone gets it. Those who are positive to an HLA-a2 factor quialify for the GP2. But, some get it plus the GM-CSF and some get the GM-CSF only. Those of us who are negative to the HLA-a2 factor qualify for the AE37 vaccine and again, only some actually get the vaccine plus the GM-CSF and some only get the GM-CSF. Becky, information you posted earlier really helped me make the decision. I have completed the initial innoculation and have had two of the four boosters. The nearest physical site for me is the Wake Forest Baptist in Winston-Salem, NC. I feel every 9 hour trip (one way), I have made has been well worth being involved in this trial.

This trial has really been a blessing to me. I am doing great. One reason it can apply to everyone is because it is looking at two vaccines. I did not qualify for one at Mayo because when they tested me, I learned that I am negative to the HLA factor. That is why I know that IF I am actually getting the vaccine, it would be the AE37.

I encourage everyone who is thinking about a vaccine trial to seriously consider this one. You should be able to get in if you are completing your Herceptin and are NED. You only have a three month window to enroll after you complete your treatments.

anna4969 · 11-05-2011, 09:24 PM

hi all
I am/was in basically the very same trial as Sandra. Thank you so much once again Sandra for encouraging me. I feel it was an excellent opportunity too. Becky, thank you for that thorough explanation! I want to mention one thing about the trial I was/am in at MD Anderson(I just have blood work now), I got the GP2 and GM-CSF while I was on Herceptin. So if anybody is still in their Herceptin treatment and is interested, I would be happy to discuss. I unfortunately was unable to have the boosters. So keeping the immunity might be more of a challenge for me. The principal investigator at MDA is basically a genius and I knew the moment I met her, that they have researched and found something(the vaccine) to likely greatly diminish recurrence rates.

One other vaccine trial that will likely be opening for low Her2 expressors, the second half of 2012, is the E75. They have finally got funding for a phase 3 trial. This one, too, really sounds like the one to take advantage of, as all those previously vaccinated with the E75, have had 0 recurrences.

These vaccines, as they have been explained to me, are so safe with relatively no side effects. What an opportunity to have!!!

Be Well everyone

)))

'lizbeth · 11-06-2011, 07:56 AM

This is great. When I was first diagnosed with Her2 breast cancer, I would have been thrilled to find a thread on vaccines like this one. It did not exist. I did not have the opportunity to receive a vaccine while undergoing Herceptin. Yet just a few years later - here it is!

I am so HAPPY to see others participating in these studies. I felt so alone and then SandraGA joined the same trial as mine. Now I see more and more joining our trial, and other studies.

Ladies, together we can make the change happen, away from devastating cancer chemo, radiation & surgeries to more sucessful targeted therapies that treat our own individual cancer.

I truly believe that the information learned from these vaccine studies will open the door to more advanced medicine in the future.

Thank you so much ElizabethTX for joining the vaccine trial.

Sandra in GA · 11-06-2011, 08:25 AM

I am posting this for further information about the trial we are in and the AE37 vaccine. The GP2 vaccine has proven to be effective in increasing the body's immune response to fight the HER2 tumors in peope who have the HLA-a2 factor in their blood. Those of us who do not have that factor has bodies that are harder to stimulate in that manner. This trial is the first to use the AE37 vaccine which is supposed to "more vigorously stimulate" that response. In the past, those of us who are negative, were only used as "controls" in these vaccine trials. This vaccine, AE37, has also been used in a prostate cancer trial and has also shown positive results there.

Thank you, Elizabeth in Texas for joining us. I truly believe vaccines will be an important component in combating this disease.

Ellie F · 11-06-2011, 10:24 AM

Hi
Could you explain what the HLA-a2 factor is please? Do they find out if you have this by blood tests? I assume it is something to do with how effectively your body generates an immune response?Googled this but got boggled with the science so a straightforward (if there is one) explanation would be appreciated.
Thanks Ellie

ElaineM · 11-06-2011, 11:33 AM

All the best to you !! Please let us know how it goes.
I would love to get a vaccine someday !!

anna4969 · 11-06-2011, 03:20 PM

Hi Ellie,

HLA factor is basically a gene/antigen typing. In my understanding you are either positive or negative. It is not unlike blood typing whereby you are only one blood type that doesn't change throughout your lifetime. Testing is just a simple blood test. The trial would pay for this test if you decided to pariticpate. I traveled from Wis. to Texas for the trial and did not want to make an unnecessary trip if I tested HLA-(for my trial you had to be HLA+) and so I asked my onc if he would test me here. He did and so I knew up front what my type was. So if you are traveling, you might want to give that a thought. But like Sandra mentioned, that is the beauty of the Walter Reed Trial, you can be either to participate.

I agree with Lizbeth and Sandra....Yeah for everyone that is considering a vaccine trial!! And ElizabethTX, thanks for starting this thread too.

Ellie F · 11-06-2011, 03:38 PM

Thanks Anna
Does being HLA+ mean you are more likely to develop a sustained immune response to a vaccine be it for bc or any other? or have i got this wrong?
Ellie

anna4969 · 11-06-2011, 03:48 PM

Hi Ellie

I don't think this is what they are thinking. I think it is simply they give you the vaccine that is best for your typing. I could be wrong, but I don't think it has anything to do with a sustained response. They are hoping to sustain your response with the boosters though and both HLA+ and HLA- get boosters. Hope that helps. I think Sandra has a solid understanding of this, and surely she will add to this or correct me.

Ellie F · 11-07-2011, 03:48 AM

Many thanks Anna, it's greatly appreciated.
Ellie

Sandra in GA · 11-07-2011, 08:43 PM

Ellie,
I have been away and am just getting home. Anna is right. The testing is a blood test and one is either positive or negative. My onc down at Mayo said that 45% of the population is positive and the rest are negative. You are correct in assuming that people who are positive develop immune responses more readily to all vaccines. The simplest explination that I was able to take away from the research I did is that those of us who are negative would make better transplant canidates because our bodies don't have as much of a reaction. That is why a lot of the trials either exclude negative participants or use us as "controls." That is why the Walter Reed trial is different. It is looking at two vaccines with the AE37 being able to stimulate us "stubborn ones."

I hope this helps. We are on the cutting edge of these treatments. There are other studies being developed where different agents are being tested and they are looking at ways to help everyone reguardless of HLA factors and types of breast cancer. I just keep trying to learn about all of them and that is impossible. I think that within our lifetimes we will see the development of vaccines that will help all cancer patients. There is so much work being done in this area.

Sandra

Ellie F · 11-08-2011, 04:31 AM

Thank you so much for the reply. I hear regularly about progress with vaccines and hope soon we will have the cure. I know one of the main problems they encounter is overcoming tolerance as cancer cells unlike bacteria/virus are our own cells gone wrong. I f they can find a way round this and help our bodies recognise these abnormal cells then i am sure we will have the cure.

Thanks again
Ellie

Becky · 11-08-2011, 06:13 AM

Ellie

You are exactly right that the body doesn't work the same with cancer as it does with viruses and bacteria. That is because there is some component in cancer that is inherently you and the body, in general, does not attack "self". This is why they are studying other diseases in conjunction with this work in which the body does attack "self" such as multiple sclerosis, lupus, rhemotoid arthritis etc. They believe these diseases where the body attacks certain organs or structures may have been caused by a virus and the body goes into overtime and attacks nerves, joints etc.

Also, it seems, that the cancer tumor itself, once it begins to be attacked by the immune system somehow changes and actually engulfs attacking killer T cells and changes them. This change then causes the body to continue to manufacture killer T cells with this changes rendering them ineffective.

Anyway, alot of research is being done on changing the way the immune system works against cancer so someday a woman in the future who has a cancerous lump will only get some shots that will dissolve and annilate the tumor - no chemo, no rads, no surgery. A couple of shots and you're done. That will be so great. One day my grandchildren will say, "what are you talking about grandma? You mean they cut you, poisoned you and burned you?"