U of W vaccine trial
 

Can someone explain what this is? Is it for stage 4...who qualifies? Is this trial still available? How are people informed of it? Thanks, Ceesun

lots of different trials
 

Ceesun,

I did the Phase 1 trial of the DNA Plasmid Her2 vaccine. In addition to the following criteria, you had to pass a blood test (looked at some inflammatory marker, can't rememebr the details, but maybe Steph N will chime in)

I learned about the trial on this site and asked my onc about it. He highly encouraged me to enroll. U of W can not reimburse you for any expenses except parking. I used my frequent flyer miles for most of my trips to Seattle. I have listed some info from the U of W website for the trial I participated in (but like Debbie said, there are a few more trials now) I would hope your oncologist could give you some guidance on the best trial for you.

Patient Population

1. HER2-neu over-expressing
2. Stage III & IV Breast Cancer
3. NED or Stable bone-only disease
4. Unable to bear children

Number of Patients: This study will accrue a maximum of 66 patients with 22 per dose level.
(Now accruing for the last dose level) Patients Visits

1. Total of 7 visits to Seattle
2. 1 Vaccination per month for 3 months
3. Follow-up visits in months 4, 6, 9 & 15
4. Yearly questionnaires to physician for up to 15 years

Other Procedures

1. Tetanus Vaccine: done at first visist
2. Tattoo: two small dots to mark the vaccination site
3. Chest X-ray
4. Skin Biopsy
5. History & Physical
6. Blood Tests
7. MUGA or ECHO (depends on current tx)
8. Research Blood Draws

I am going to take information about the trials to my oncologists on the next visit. I hope that I can get in the trial.

Amelia

U of W Vaccine Trials
 

Hello all-

I have been following this board for a little while, but this is my first post. I have just been accepted into the peptide based vaccine trial at the University of Washington and will be traveling out there next week for my first visit.

I welcome any experience that any of you have had with U of W and I will certainly keep you all posted on how the trial is going.

I'm so glad that I found this amazing group!

Regards-

Suzanne

Hi Suzanne, First of all...welcome to the board. I'm sorry you had to join us for obvious reasons but as you know by now it's a great group of woman & men. I'm glad you decided to jump in and post. :)

That's exciting that you were excepted in the vacine trial. I wish I could afford to travel right now because I would love to get involved in that trial also. Please keep us informed on how it's going.

Chelee

Hello Suzanne,

Congratulations on being accepted into the vaccine trial. Please let us know how things are going.

Amelia

Suzanne and Amelia,
Based on this thread, I spent a few hours (ok...most of Saturday) researching breast cancer vaccines on the web. There were 3 or 4 different locations that seemed to surface:

OOPs...this is Lori again. I don't know what I fat fingered.

Anyhow.....there appears to be research underway at:
Mayo Clinic
Wayne State
U S Military Cancer Institute

So...Suzanne, when you spoke with your Dr., how did you settle on the University of Washington trial? Is it the furthest along? Most promising? Possibly a practical matter of the only location with an open trial?

Amelia, would you be willing to share the thoughts of your Dr?

I plan to discuss potential vaccine options with my Dr. at my next appt. in mid-january, so any insights would be appreciated. (I always seem to fall victim to coming home after an appointment and THEN thinking of all the things I should have asked)

Let's keep this vaccine thread going!!

Lori

Suzanne,

My experience at UW was all positive. They are very organized, compassionate and appreciative that you decided to participate. The days were long, I traveled from central CA to Seattle and back the same day mostly. A lot of poking, but they did treat me very well. I enjoyed visiting Seattle, what a great city.

I did not have any side effects other than a little fatigue and minor inflammation at the injection site after the vaccine was administered.

Best of luck next week and tell Doreen hi for me! And if you have any other ?'s, please ask.

Margerie

Do ALL of these visits need to be coordinated in Washington or can you have your current cancer center do any of these procedures or steps?

Also, can you explain the vaccine? What kind of vaccine is it? Are there any known risks with this vaccine (i.e. "live" virus vaccine vs "dead" virus vaccine)

Thanks VERY much,

Terri

Terri,

As far as I know, you must go to Seattle for all 7 visits. I asked the same question, but it wouldn't hurt to ask again as maybe they changed the protocol.

There are some preliminary tests that are done at your oncologists office to qualify. These include a blood test (which UW paid for) and a MUGA or echo, which they did not pay for. Luckily I was due for one anyway and my insurance paid for it.

In the study I did, there was no virus. It is a plasmid based vaccine:

Study DesignIntradermal administration of 3 doses of a plasmid-based DNA vaccine encoding the ICD of HER2 administered with a fixed dose of GM-CSF.
**************************************
The GM-CSF part is a wbc booster, similar to neulasta. But if I remember right, a much smaller dose. The vaccine itself is based a portion of the her2 protein and the hope of the study is that you will have a measurable immune response to this. I asked about toxicity (to heart tissue and others) and they had not seen any yet. But measuring toxicity is part of the study and I started in Jan. 07, so almost two years ago.

I highly encourage anyone interested to contact the study director
Nicole Bates

nbates@u.washington.edu

She is wonderful about getting back to you and answering your questions.

Vaccine info.
 

Hi everyone,

I'm excited to hear the vaccine trials are still going on. I participated in the phase II peptide trial from January 07-June 07. I was stage IV, but NED at the time. NED status was required for my trial. There were a number of other criteria, including being no more than six months from starting Herceptin alone. It was a scramble to qualify in time, but my onc. and everyone in Seattle did a great job getting me in with 5 days to spare. Doreen, Becks and all of the folks in Seattle were completely amazing. I was on my own (since my husband was needed to stay home with the kids) in a city a million miles away from the my home in the "other Washington" (D.C.) but after that first visit I never felt alone. Expenses were a bit rough. You are responsible for all of your travel costs. However, I was able to secure two plane tickets from Southwest Airlines and one from Continental Airlines. Both of these airlines have a humanitarian medical treatment program that folks like us can qualify for. Super low cost internet fares were another break, but keep in mind I did most of my traveling in the winter months. The best break I received was through the American Cancer Society. They have a program that allows cancer patients seeking treament to qualify for low cost or no cost hotel rooms in their treatment city. Five out of my seven visits included free hotel rooms. You cannot choose your hotel, but they were extraordinarily nice hotels. The only glitch is getting transportation to and from the hospital, hotel, airport etc. It can be super costly to take taxis. However, once I got the hang of it, the bus system in Seattle is great and folks were so friendly and helpful. All in all I can't say enough about my Seattle experience. I even met a fabulous fellow vacciner: shout out to Karina!! I don't know if it is the reason I am still NED today, but I believe it has helped me tremendously. I know when I got on that plane for the very first visit, I was completely drained and without hope. We all know the devastation of hoplessness. I left there believing I had a chance. Is there a greater gift?

Missyw that is such good news. Have you heard the results from anyone else in the same study?

Best,

TRS

Vaccine Anyone else?
 

Hi Terri,

Due to confidentiality rules, the folks in Seattle can't let us know about each other. I was getting my shot one month and Karina was there at the same time. The nurses let us bump into one another and of course we found out we were there for the same reason. It was great having her there when I was by myself. She posts here often as "full of beans". At the time of her last post, she too was still NED!!!

Wow. Is this the trial that is open to stage 3 or stage 4?

TRS

Vaccine info.
 

Hi Terri,

I believe this trial is open to stage 3 and 4. Originally it was a stage 4 trial. However, I recall the nurses telling me that they wanted to cast a wider net, so they were opening it to stage 3ers as well. Best of luck!!!

Missy