Walter Reed Vaccine trial

['lizbeth]

Hello all,

I am headed out to San Antonio January 6 to 11th to participate in the vaccine trial.

I'd love to do lunch or a dinner if you are a San Antonio local.

Warm regards,

'lizbeth

[Yorkiegirl]

Lizbeth I thought Walter Reed was in DC???

[Adriana Mangus]

Hi Lizbeth;

I also live in the San Diego area. Good to know there is someone near who belongs to this group. Great news....

['lizbeth]

Walter Reed is in DC, but the vaccine trial is at other Army locations. The closest one to San Diego is San Antonio.

[Jackie07]

'lizbeth,

I would love to take this opportunity to meet you at San Antonio - been there three times (in the 20th Century :)and loved it. But I'm afraid I won't be recovering well enough from my surgery (a week from now on the 10th) to make the 6-hour 'round' trip. Alas...

Do think of us while you are on the Riverwalk...

[schoolteacher]

'lizbeth,

I am excited about your participation in this trial. Please let us know how things go. How many vaccines will you have to have? What is the name of the vaccine?

Amelia

['lizbeth]

Amelia,

I have a 50/50 chance of receiving a second generation vaccine. Since I am HLA-A2+ it would likely be the GP2 peptide vaccine. Or I might be randomized to the Leukine arm which has also shown benefits with cancer.

Either way I hope to reduce my chance of recurrence and hopefully in the future give others an opportunity for treatment other than chemotherapy.

Officially I won't find out what I receive until disease progressions, a medical problem or the end of the 5 year study.

I'll let you know how it goes.

'lizbeth

[Joan M]

Lizbeth,

Do you have specific information about this trial? Which one is it? Do you have a link? I tried searching on this site and came up with E75 vaccine, but when I looked at clinicaltrails.com with that search term, it was unclear.

Also, is this trial for advanced or early stage bc. I'm not sure what "disease progression" means in this context. It seems like you might be early stage, but I'm not sure.

Good luck with the trial and keep us posted.

Thanks much.

Joan

['lizbeth]

http://clinicaltrials.gov/ct2/show/NCT00524277?intr=%22AE37+peptide%2FGM-CSF+vaccine%22&rank=1

[Sandra in GA]

'lizbeth,
Do you have to be HLA-A2+ to participate in this trial?
Thanks,
Sandra

['lizbeth]

There are 2 arms in the Walter Reed vaccine trial. One for the GP2 peptide/GM-CSF and one for AE37 peptide/GM-CSF vaccine.

The GP2 is for HLA-A2positive, the AE37 is for HLA-A2 negative.

The control is GM-CSF which we would have a 50% chance of receiving. The GM-CSF is Leukine which is currently being used in the treatment of leukemia.

These are 2nd generation vaccines.

['lizbeth]

Joan, E75 is the first generation vaccine. There have only been a few small Phase I trials with the GP2 and AE37.

[Sandra in GA]

Thank you so much Elizabeth. I am hoping to get into a trial, but I have not been tested yet. It will be after February 19 before they can test me. I am glad to see that this trial offers arms for people both positive and negative. You should feel lucky. I have heard that only about 45% of the population is positive and those benefit most from vaccines.
Sandra

['lizbeth]

Sandra,

I thought being tested was part of the trial. I just happened to get tested before. That brings up a good question, why have the AE37 vaccine for those who are negative? There must be some evidence that it is effective or companies would not spend millions of dollars pursuing results in a clinical trial?

I feel very lucky to be part of this trial. I am hoping that Balboa NMC in San Diego is approved soon so that I don't have to make too many trips out to San Antonio.

Elizabeth

[Sandra in GA]

You are right. I am a patient at Mayo in Jacksonville and have been trying to get into their trial. Since I took my last Tykerbs on Nov. 17th, they won't test me until after Feb. 17th. Their trial only includes the positive folks. They are not offering anything for the negative folks. They are not offering the EA37 vaccine, so that would explain why they had told me the vaccine they have would not be effective for neg participants.

Since I live in south Georgia, Jacksonville is less that three hours away by car. However, if necessary, I can get to North Carolina for the vaccine.

Thank you so much for your answer. I am like you. I just want to beat this disease in the head. I have been in a trial for early HER2+ breast cancer patients that combined Tykerb (lapatinib) and Herceptin along with all the regular chemo and radiation. I do hope the vaccine will help me but I also hope I can help others not have to go through all I have. My children are grown, but they have already lost their father to brain cancer and I do so want to be here for my grandchildren. The youngest is only two. My only granddaughter will be four in Jan. and my visualiation is being at her wedding!

Thanks a million~
Sandra

[krisvell]

'Lizabeth;
How did you go about deciding which Clinical Trial was right for you? I contacted Walter Reed as I am interested in the BC Vaccine Trials. They sent me the information but said I need to wait until all my treatments are done (end of June '10). It would be a real hike for me to go do DC but I am willing to make the sacrifice to stay NED. Any advice would be appreciated.

['lizbeth]

Krisvell,

I only found 2 vaccine trials that I qualified for (there might have been more, but I didn't find them).

I didn't read the Mayo clinic information closely enough to see I had to be enrolled within 3 months after primary treatment.

The Walter Reed was within 6 months after primary treatment. One of the principle investigators for the trial works at Balboa NMCSD where I am a patient. They tried to obtain approval for the trial at my location, but didn't go through IRB in time and I had to fly to another location to participate.

Mayo clinic is offering a vaccine that works with something other than HER2. The Walter Reed trial is a phase II for GP2(HLA-A2+) and AE37(HLA-A2-). I am the human lab rat that will show whether or not the vaccines are effective, lol.

I asked my oncologist to have my blood tested to see if I was HLA-A2+. From the posts on this website I had gotten the impression that if I was HLA-A2- that a HER2 vaccine wasn't available for me.

My advice is to find all the trials that you might qualify for and obtain as much information as you can. Call folks up who are responsible for the enrollment and start asking questions now.

I drug my feet and almost missed being enrolled.

[Becky]

I think one of the reasons that you need to be close to when treatment ended is that there can be reminants of cancer or dead cancer remaining for the dendrites to find (dendrites are what "finds" the "invader") so they can rush to the lymph nodes and get the immune response started.

For the record, this is why I took Leukine as my white blood cell booster over Neulasta during chemo (87 doses to be exact). One criteria for that is that there were lymph nodes remaining on the cancer side (I had 10 removed so there were plenty left). My rationale was that by taking the Leukine, I was, in effect, hopefully self vaccinating.

I am still here over 5 years out so who knows. I did Leukine because at the time, Herceptin wasn't available in the adjuvant setting and I was node positive and I thought it would give me the best shot considering there was no Herceptin yet.

Oddly, right after chemo ended, Herceptin was available so I did take that solo (without chemo).

In the end, one never really knows what part of treatment works - was it just the surgery alone, chemo, rads, Herceptin, Leukine?

Just wanted to share that I've had my share of Leukine too. If you have any questions on it, I do know all about it - how it works and the side effects.

['lizbeth]

Becky,

I'm going to start posting on my on thread insteading hijacking Elle's.

I get the worst headaches and muscle & joint aches from Leukine. Did you get those too?

My blood pressure also increases when I get the injections, but drops after an hour.

The funny thing is before the "vaccine" I was having an extemely difficult time cognitively. I don't know if it is the GP2 or the Leukine that is working but I am doing significantly better physically, and as a result of good health, emotionally.

I look at the previous studies and I see a benefit to the HLA-A2+ from the first generation vaccine E75. A2+ cancers are larger, more aggressive. If the vaccine lowered the recurrence rate and the mortality rate as shown in the publishings on E75, then the medical industry needs to reexamine their objectives.

My study will show if the second generation vaccine for A2+ is effective. And as a bonus there is an arm for the A2- with the AE37 vaccine. Blindly randomized.

I'll let you know if I get an autoimmune disease or a heart attack and then you can tell me you told me so, lol. I'm so excited to be the vaccine trial. It will be great when it is finished so we can all see the effectiveness.

I have the results of the Phase I results of my trial which is dogearred from reading. It just was published in Cancer, and has probably already been posted to this board, somewhere.

[Becky]

I was a Leukine side effect poster child. The drug does rapidly lower blood pressure after about one hour. I was extremely weak on the Leukine (got a shot everyday for 10 days in a row during every chemo cycle). I got hives at the injection site (they moved the site everytime) starting on the 7th injection and thereafter. This is supposed to be a GREAT thing as it is showing an immune response. However, I had to be extremely careful about coming in contact with anything I was allergic to. One time, we went out to dinner and I ate food I always eat but there must have been something that I am on the edge with and my lips swelled (gigantic) and I took lots of benadryl but it took 24 hrs to subside. I was a wreck then. The first days of every cycle I had tremendous bone pain. All side effects were worse in the beginning than they were ongoing. However, the lip swell thing was the cycle after my first Taxol (I did 4 AC then 4 taxol dense dose). So I think the allergic thing was in full gear as I had big problems with hives all over my body with Taxol so the Leukine didn't help me much there as this was intensified. Bad enough to have to get an epi-pen. But I persisted to stay on as I really believed in Leukine and I also felt the immune response assisted as I refused decadron as that also negatively affects the immune response. I depended solely on benadryl which is a drug that does not affect the hoped for action of Leukine (and the dendritic effect).

I was exhausted but felt like I was winning the war. Going to the cancer center all the time was no joy either.

I remember when I went back to start Herceptin and I asked what kind of side effects and was told "allergic reactions". All I did was laugh out loud. I'm sure they thought I was nuts but it was not anything like my reactions to Taxol when I was on Leukine!!

Keep on trucking.

['lizbeth]

Becky,

I have this tingly lip thing going on after my injections They don't look swollen.

Can't do benadryl, severely allergic.

My blood pressure goes up to 140/100 and then starts easing down. So I don't have the typical Leukine reaction there. And I don't have bone pain, its more of a joint ache and muscle ache.

Next week my dose of Leukine will be reduced and I am hoping I won't have that terrible headache.

warm regards,

Elizabeth

[Nancy L]

Congrats on getting into this trial. I have been following Dr. Peoples work for sometime and many other vaccine research projects. Unfortunately, my cancer progressed before I could get enrolled in a vaccine trial.

I hope you have an onc that is supportive of vaccine trials. I have yet to find one that believes in any of these vaccines. I hope that brave women like you prove them all wrong.

['lizbeth]

Nancy,

I'm really lucky to get into a vaccine trial. My doctor is delighted and supportive.

I hope the medical industry will start to embrace treatments that work with the immune system and give a better quality of life. I believe the vaccine is making a difference for me.

I don't think of myself as brave, just highly motivated. If I sit back and wait for the cancer to metatisize then I will not be able to get my pilot medical certificate back for 5 years. And I am too young to be ill, I want to be healthy!

Plus I told my nephew that cancer treatment would be better for his generation. I intend to do my part to see that it is. I am determined that women in the future have better choices for treatment than we did. Stubborn, maybe, not brave, lol.

This is exciting to me. I hope the results of this study help to change the industry attitude toward vaccines as a treatment. In this study we might find 2 ways to reduce reccurence and mortality, vaccine and GM-CSF.

Peoples mentioned a new study combining GP2 with Herceptin. He says the Phase I of my study showed that it affected 3 pathways.

The more treatments the merrier!

[pennyvphoto]

I have also been on trial am HLA negative,so far have not had any severe adverse reaction,but am on trial in europe.

['lizbeth]

Penny,

Are you in an AE37 arm? Or is it a different vaccine?

[pennyvphoto]

Am HLA2 neg so AE37 /gmcsf ,have finished trial now and am on boosters .

['lizbeth]

Pennyvphoto,

I just found out my trial is approved for boosters. Thanks to your post it prompted me to ask.

Good health,

Elizabeth

[Sandra in GA]

Elizabeth,
I went up to Winston-Salem last weekend and am now in the trial! I will be going back the week of April12th for the week long first visit with scratch tests and the injection. They had to redraw my blood because Mayo had tested me for HLA-B27 instead of HLA-A1. I am assuming I will still be HLA neg. because that is what the first test showed. However, the nurse said I may not be. She was uncertain if they were going to offer the boosters there, so I talked with your nurse at Fort Sam Houston and she assured me that all participants would receive the same treatments. She was extremely knowledgeable and helpful. I kinda wish I had chosen that site. My husband is retired from the Navy, so I am familiar with military facilities. I chose the North Carolina site because it is the nearest. So I will begin there. I feel so lucky to participate in this as I know you do!

Sandra

[pennyvphoto]

Lizbeth
Do you know how long the boosters are epected to last?or does no one know yet?

['lizbeth]

Shoot Penny, I signed the form for the boosters and forgot promptly where I put it. To my recollection 4 injections of the control arm received every 6 months for the booster shots.

[Unregistered]

I am only allowed 2 as have been on trial since aug 08 ...do you know how long they last?

[Sandra in GA]

Hello to All,
I am up in Winston-Salem NC and have just received the last of my six inoculations! This has really passed quickly and with very few side effects. Wednesday I go back over to Wake Forest Baptist Medical Center for the nurse to evaluate my reactions. I will return in three weeks for the scratch tests. I have been told they are going to offer the boosters up here also, but they don't have their paper work together yet. Surely, they will when I come back. I feel so fortunate to have been included in this trial. This is the only one that is looking at vaccine for HLA-A2 neg. people. In other trials, they have been used as controls. The vaccine I have been hopefully getting is AE37 peptide vaccine. Recently, results from a phase I trial using this same vaccine for prostate cancer patients has been published showing positive results for these patients also.

I feel great and in July I got a report of clean scans and a normal CA 15-3!!! So, I am now a TWO year SURIVOR!!!

Thanks to this board, I learned about the Walter Reed vaccine trial. I will be forever grateful. Thank you for all of the encouragement and advice so many of you have offered me. This disease has humbled me by the response of not only family and friends but total strangers as well.

Thanks to all of you,
Sandra

['lizbeth]

Sandra GA - that is great news that you are finishing up the 6 months. I am so excited that you have hit the 2 year "SURIVOR" mark! I'm coming up on 3 years in November. Gosh does time go by fast.

Before you know it you be getting your booster shot.

To good health,

'lizbeth