BC Vaccine – Looking for your Thoughts

[krisvell]

I'm trying to be pro-active with my health and found two Vaccine Trails that appear might be worthwhile for me to participate in. I haven’t officially applied but have received detailed study information. I’m not sure which is better than the other --- DNA Phase I or Peptide Phase II Randomized.

I know that my BC was advanced and at a high risk for recurrence. I was hoping the members of this Discussion Board would share their wisdom with me. It will certainly help me sort thru this so I can make a decision - Apply to one of these trials or wait to see what’s down the road.

Any feedback is greatly appreciated.

* Phase I: Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer http://clinicaltrials.gov/ct2/show/N...=1&show_xprt=Y

A Phase I Study to Assess Safety and Immunogenicity (04-101). Summary: New research in breast cancer attempts to use vaccines to trigger the body’s immune system to fight cancer. An injection of a small amount of cells (DNA that encodes the HER2 protein) into the body may trigger an immune response against other breast cancer cells in your body. The purpose of this trial is to determine the highest dose of the HER2/neu immunization that is safe, and see if it can stimulate an immune response in women with metastatic disease or at high risk for metastatic disease.
My Thoughts:
- Would get the vaccine
- Site location Memorial Sloan-Kettering is close to home
Rare but serious < 3%
“….It is possible that an immune response to this injection may affect the response to future treatment with trastuzumab..”
“… theoretical possibility that this DNA could combine with your own DNA and cause tumor development.

* Vaccine Therapy in Treating Patients With Breast Cancer http://clinicaltrials.gov/show/NCT00524277

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells that express HER2/neu. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy is more effective than GM-CSF in treating breast cancer.
PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with GM-CSF in treating patients with breast cancer.
My Thoughts:
- 50% chance of getting the vaccine
- Site location is far – would take 7 hrs
Rare but Serious < 1%
Medical side effects – (e.g. Low blood pressure, sudden allergic reaction to GM-CSF)
Nothing rmentioned that could potentially compromise future treatments.

[Jackie07]

Kris,

Both of these trials sound hopeful. You probably want to go ahead apply for both to increase your odds of getting into a trial.

['lizbeth]

Whoa there! Krisvell - I just read the Phase I Sloan Kettering trial was for Stage IV metastic patients who have a life expectancy of less than 6 months. I read your history and it looks like you just finished primary treatment.

The Walter Reed vaccine trial is the one that SandraGA and I participated in. It is for folks like you who just finished Herceptin in the last 6 months. So don't wait - get on the phone and start the enrollment process. Time goes by fast and I wouldn't want you to miss this opportunity.

Both Sandra and I agree - we feel soooo much better after participating in this vaccine trial.

I know the Mayo clinic also was offering a vaccine trial for primary breast cancer - BUT! you have to enroll within 3 months after finishing Herceptin.

Let me know if I can help,

'lizbeth

[krisvell]

Thanks for your posts. I also spoke to Sandra from GA and your ideas helped. I'm going to take your advice and pursue both. I just wish I could find someone to help me figure out which might be the one for me (provided that I qualify).
Kris....

[Sandra in GA]

Kris,

I know this is a very difficult decision for you. After talking with you the other night I looked at the Sloane-Kettering trial. I am sorry it has taken me so long to respond to this thread. I fell over a small stool a week ago and broke a bone in my right hand. So, I am typing with one paw. Anyway, there are a couple of concerns I would have with this trial;
first- it is a phase I trial. This means this vaccine does not have any data showing it will work. The Walter Reed study is a phase II. The data from the phase I is supporting continued study with the two vaccinrs they are using.
second-there is a possibility that this vaccine could cause tumor development. The vaccines used in the Walter Reed study are both peptide based which stimulate the immune systems in the participants and are NOT going to cause tumor development or one to progress.
third-as you mentioned, the vaccines in the Walter Reed trial do not interfere with future treatments with Herceptin if needed.

It is your decision. But, please think about these concerns. You have come a long way. At this point, I would not want to risk too much.

I truly believe that my participation in the Walter Reed trial has given me some extra protection. As a matter of fact, I am now in North Carolina and will receive the final DHT TESTS TOMOROW. They are now offering four boosters at six month intervals and I hope to get those.

Good luck and please let us know what you decide.
Hugs,
Sandra

['lizbeth]

SandraGa,

I checked your history and you started the vaccine trial on my husband's birthday. How cool is that?


Krisvell,

Start applying to both. Future cancer patients will benefit from whichever decision you make and the Her2 board, of course, will put in our 2 cents to help you make a decision.

[Sandra in GA]

'lizabeth,
That is really neat! I got my first chemo on my birthday. I think both these instances are good omens!

Kris, I think 'lizabeth has a good idea about applying to both.

Sandra

[Ellie F]

Hi
I have also looked at the vaccine trial at MSKCC and have discussed it with my onc here. Whilst I appreciate it's phase 1 I understand the research leading up to it was very sound coming out of a world famous treatment centre. I am currently waiting for info from other trials to compare them.
One of the issues for me is that with all vaccines currently in trials it appears that they may confer some short term immunity but overcoming 'tolerance remains a difficult problem.Whilst most of them seem able to generate both cellular and humoral responses it remains uncertain as to whether this alters long term outcomes.I am really, really hoping that soon some researcher will find a way round these difficulties.

Ellie

[krisvell]

Thank you for ALL this information. I'll keep you posted. What great information.

Kris...