Vaccine Successfully Enters Phase-II Trial

[eric]

http://www.allheadlinenews.com/articles/7011409961

Washington D.C. (AHN) - A breast cancer vaccine currently being tested in a Phase II trial at various hospitals has yielded positive results and is targeted towards women who've already had metastatic breast cancer.
The therapeutic breast cancer vaccine AE37 uses a peptide antigen of a cancer gene known as HER-2/neu. This gene/protein is present in many types of cells, but it is over-expressed in a high proportion of breast cancers as well as many others.
Researchers say that they are seeking to evaluate the efficacy of two anti-cancer vaccines targeted to the HER 2 protein, which is expressed in 60 to 70 percent of all breast cancers.
Researchers believe that if the woman if an immune responder, she has double the survival rates as compared to non-responder.

[Janelle]

It was my understanding that this trial is NOT targeted toward women with metastatic breast cancer. My understanding is that this vaccine is being tested in HER2 positive women who are currently NED but at high risk for recurrence and have never had a metastisis. The goal is to try to find out if the vaccine prevents spread.

I also understand that the reason they are testing this out in non-metastatic women without current evidence of disease is that in theory this particular vaccine may work better in women with a low disease load.

[Rich66]

"the HER 2 protein, which is expressed in 60 to 70 percent of all breast cancers."

60 to 70 percent? They must be including some who are currently considered her2 negative.

[Janelle]

Yes, I was wondering about that 60-70% stat too. I figured it must include those who overexpress HER2 to a slight degree. There is a subset of Her2 positve population that overexpresses HER2 but are not candidates for Herceptin because they don't overexpress it "enough". From what I understand the "low" HER2 overexpressers is the population that benefitted the most from this vaccine in the phase I trial. But it is possible that the high overexpressers don't see as great a benefit because they were previously pre-treated with Herceptin.

I am a high over expresser of Her2. I'm starting this trial on Monday. It probably won't do me any good....and I have a 50% chance of getting randomized into the placebo arm. I'll let you know if I learn anything new. I'm enrolling at MD Anderson.

[chrisy]

I think this is just a badly written article, and the writer got the stat wrong. It says the Phase I trial was with node negative, so definitely not metastatic.

To me, it's not clear if people with metastatic history would be eligible for this trial or not...it doesn't specifically EXCLUDE but you do have to be NED. So it's hard to tell if the study really includes those people or if it another instance of "badly written or misunderstood" Link to the trial is below.

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

[dhealey]

I am currently enrolled in this trial at Wake Forest @ Baptist Hospital in Winston Salem, North Carolina. I have had my 3rd vaccine last week and have thus far tolorated them well except for a great deal of swelling at the injection site that lasts for about 1 week. This is very exciting as it is the beginning for finding a vaccine to prevent Breast Cancer in all women. Right now they are seeking women who are no longer than 6 months out of treatment, high risk and her2 poisitive. Glad to hear you will also be starting the trial Janelle. Good Luck

[Janelle]

Thanks for the encouragement, Debbie. Do you bones hurt after the injection?

Any other symptoms? I was told I might experience flu like symptoms.....I just want to mentally prepare. Thanks!

Janelle

[dhealey]

Janelle, I do not have any bone pain from the vaccine. I do feel tired for about 24 hours after the injection, sometimes with a slight headache about 2 hours after getting the injection, but this goes away by the next day. I have so far found this to be very tolerable. Best of luck! Debbie

[Shobha]

Hi, can anyone tell me how to enroll in this trial? I was diagnosed with Stage IIIb Her 2 positive cancer in June of 2007. I finished my treatment in July 2008. Thanks!

[Janelle]

You need to enrol within 6 months of your last herceptin treatment. I can give you more details later....just remind me. I just got home from a wedding and I need to fly to MD Anderson tomorrow....YIKES!

Otherwise, maybe Dhealty (Debbie) can direct you to info about the trial.

[dhealey]

Shobha, The clinical trial can be found on www.clinicaltrials.gov (http://www.clinicaltrials.gov) search for the trial by this NCT00524277. The trial is being conducted thru Walter Reed Hosp. in DC There are six testing sites here in the US and 1 in Greece. I am participating in the on at Wake Forest Baptist Hops. in Winston Salem, North Carolina. You must be her2 positive and no longer than six months out of treatment.

[Shobha]

Thanks Debbie and Janelle! I was Her2 positive and my herceptin treatment finished on July 11, 2008. Since it is within 6 months of my last herceptin treatment, I really really hope I can get enrolled.
I am 40 years old and have two children 5 and 4 and want to see them graduate out of college so very much !!

[Janelle]

I had my first injectin on Wednesday, Oct. 15.

I experienced fluid retention in my ankles within 2 hours of receiving my first injection. Apparently this is a somewhat uncommon side effect but they have noticed it in 10% of the patients so far. I was also very tired for the next 24 hours and I still feel more fatigued than usual today.

I had very minor swelling at the injection site but I was told this could get worse after subsequent injections. Of course, I may be getting the placebo arm too....

[Carolina59]

I am currently trying to get all the paperwork, records, etc. together to enter this trial before my window closes on 2/15/09.

Does anyone know how many patients are enrolled so far at Wake Forrest?

Thanks,
Carolina

[Janelle]

Where do you live? Fewer than 10 people are enrolled at MD Anderson right now. I can try to find out from MD Anderson if they have the enrollment stats for Wake Forrest.

[Carolina59]

Thanks, Janelle. I am in NYC, but I have a cousin in Winston-Salem, and I grew up in Charlotte, so I think that would be the easiest place for me to go. I also have a 4 y.o. dd, so I have to figure that in to the traveling logistics, esp. since I was told I would have to spend a week there for the screening process.

I am still interested in how many are enrolled at Wake Forrest--in July someone posted that there were only 2 people enrolled. I'm sure they must have more now. I forgot to ask the nurse coordinator.

[Janelle]

Carolina,
See below from Dr. Mittendorf at MD Anderson. I'll update you when I receive more info.
Best,
Janelle


Janelle-

I don't know the answer off the top of my head but have made an inquiry to Maureen Pavlik who should be able to find that information for us. Where is the patient living? If Houston is not out of the question I would be happy to help her enroll here.

Beth

[Carolina59]

Thanks, Janelle, I'll wait for your update.

Are you still retaining fluid in your ankles, or has it gotten better?

xo Carolina

[Janelle]

No, the water retention only happened once. It was hot in Houston when that happened and I had just flown in and I was probably dehydrated from a wedding weekend. I'm not sure if dehydration would make one retain water though. The swollen ankles did freak me out a bit but it turned out to be nothing to worry about.

[Midwest Alice]

Janelle,
Do you have to be done with Herceptin to start the trial at MD Anderson?

Thanks

[Janelle]

Alice,
Yes. You must enroll in the trial with in 6 months of your last Herceptin treatment. To be eligible you must be NED but at high risk for recurrence.

Let me know if you have other questions.
Janelle