Vaccine Clinical Trials

Christine · 09-11-2006, 08:13 PM

Several of our members have participated in various vaccine clinical trials at Univ of Washington and Walter Reed among others.

Has anyone had a recurrence?

Hugs
Christine

Lolly · 09-11-2006, 09:06 PM

Christine, I participated in the Phase I-II Combination Immunotherapy Intracellular Domain (ICD) Peptide-Based Vaccine at University of Washington/Seattle which allowed concurrent Herceptin while receiving 6 vaccine injections over 6 months, receiving the first vaccine in January of 2005 and the last one in June 2005. In October of 2005 I was diagnosed with a recurrence to the right axilla nodes; pathology of the fine needle biopsy confirmed Her-2 neu+++, ER/PR-, the same as primary bc. After 6 months of Navelbine/Herceptin, and now into 5th month of Xeloda/Herceptin with little change my med onc recommended radiation to the right axilla as the primary bc was on the left side and I've never had rads to the right. I had the 4th treatment of 33 today. My rad onc feels we have a good shot at eliminating this problem area...
Hope to then qualify for another trial at UW/Seattle!

<3 Lolly

sherri · 09-11-2006, 10:10 PM

Hi Christine,

I had my last Vaccine in March (with Herceptin) and so far I'm doing very well. I'll go again at the end of September, they will do a test to see how my body will react to HER2. I know Michelle also is NED and most of the others who had Vaccine.

I look forward to see you in November for Cure Conference.

Big hug,

penelope · 09-12-2006, 09:36 AM

Where do we find info about the trial? Do they accept stage 1?

michele u · 09-12-2006, 12:42 PM

I did the DNA vaccine trial in Seattle WA. Started Aug 2005 and had my last checkup in August. i'm going to do another vaccine trial starting in October. don't know whre yet, but this one will be a viral based vaccine. I'm ok so far.

Julie2 · 09-12-2006, 01:21 PM

I finished all the three vaccines of the DNA trial in UW. Going for followup checkup

Brian · 09-12-2006, 01:51 PM

Just to let you know, my wife, Lisa, took six of the U of Washington vaccine treatments in late 2004 and finished in January, 2005. Although she initially had a strong immune response from the vaccine she suffered a recurrance of cancer on old scar tissue from a previous tumor in her lung in January, 2005. We sent slides of the tumor samples to U of Washington which revealed that Lisa's immune system was actually attacking the tumors which everyone felt was good.
Shortly after Lisa went on chemo with Gemzar and Herceptin. She then presented with a small brain tumor in April, 2005 which was Gamma Knifed, and the cancer again appeared in a couple of areas of her liver that had been previously subject to RFA. These areas were RFA'd again and she went on 6 months of Xeloda and Herceptin.
She has been NED since the last RFA treatment.
She has sent subsequent blood samples to U of Washington, but they showed no immune response remaining.
We are looking for a new vaccine trial as we speak.

Lisa and Brian

michele u · 09-12-2006, 10:11 PM

Brian, They are starting the new vaccine trial in Seattle this october. It is a viral based vaccine. Our bodies recognize and fight off viruses and not protein very well. they will put the vaccine in a virus this time. It will be in 11 different centers across the country. Call Patty Fintak and ask about it

DonnaNY · 09-12-2006, 10:17 PM

Could you please tell me how to contact Patty Fintak? Thank You!

Joe · 09-13-2006, 06:53 AM

To access clinical trial information, just go to our clinical trials page:

http://www.her2support.org/a/newher2.htm

Regards
Joe

Cynthia · 09-13-2006, 08:25 AM

Hi Michele. I am glad to hear that you are still well. Is this trial currently discussed as one of the U of W trials on the Clinical Trial page? A number of trials are listed there, but I wasn't sure which one you are referring to. Also, do you know if this trial accepts patients who have never had mets?

FYI, I completed the Walter Reed vaccine trial in 2004, and so far so good.

Cynthia

Dx 9/03 at 43 years; 4 nodes +; Her2+++; Er/Pr+; CAF x 6; rads; bi-lateral mastectomy; Walter Reed vaccine trial; ovaries removed; Arimidex; received one year of "late" Herceptin.

Kim in CA · 09-13-2006, 10:13 AM

Christine,

I did the same vaccine trial as Lolly and Michelle. My last shot was in December of 2004. I have been NED in my body, but did have a single brain lesion last summer that was treated with Gamma Knife. My most recent brain MRI (last week) still shows everything to be normal. Thinking about other possible vaccine trials to try next.

Kim in CA

mamacze · 09-13-2006, 09:11 PM

Hi Christine,
I did the same vaccine as Lolly, Michele, and Kim from Calif; I have been NED since Nove of 2004. I think I will contact Patty to see if I can participate in the viral one; I think a viral vector makes alot of sense.
Love Kim from CT
ps beautiful picture of you!

michele u · 09-13-2006, 09:58 PM

to All,

i don't think the viral vaccine is on the website yet. When Patty emails me more info i will let everyone know

Barbara2 · 09-15-2006, 01:25 PM

I would be interested in that trial, too. I see my onc next week and would like to give him the info for discussion purposes.

Thanks, ladies!

Barbara

Lolly · 09-15-2006, 05:07 PM

Ladies, here's an earlier post from Steph in Seattle about this vaccine, and a link to ClinicalTrials.gov with the trial criteria; note that the study is not yet open, but as Steph says anyone interested in getting on the "list" should contact Patty Fintak - Study Coordinator for University of Washington Tumor Vaccine Group: 206-543-6620.

" HER2 vaccine blues - but wait ...
Well gang, I am once again disqualified from a vaccine trial due to something in my body chemistry. My ANA (antibodies to nuclear antigen) is still positive, so that must be the way I am. This means the DNA vaccine trial at the U of W is out for me.
Still have not seen my FISH number, but that may not matter any more.

There WAS one BRIGHT spot in a message from Patty at the U of W Tumor Group.
She says there is another vaccine that will begin a phase II study the end of summer. It is not specifically a HER2 target, but works against 5T4, something common to tumors of various origins.
Only thing is :
"This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB or stage IV breast cancer in remission."

Remission is required for this Trovax study and at this time I qualify. The trial criteria says that bone mets is the only qualifier, but Patty says that has been changed and the patient can have had mets anywhere and qualify. They are updating the wording.
If interested check this link:
http://www.clinicaltrials.gov/ct/show/NCT00227474?order=1

amccreery · 10-26-2006, 08:54 AM

My oncologist referred me to U of W to participate in the HER2neu trial. I am stage 4 (BRCA2, HER2neu+, ER+, PR+) with stable bone-only mets. She thought the HER2neu trial would be more beneficial than the TroVax trial because it targets HER2neu. But after I read some posts on this site about the new virus-based vaccine, I asked her again and she said she couldn't make a recommendation.

Does anyone have insight into which trial might be more beneficial?

Thank you,

Alison

rinaina · 10-26-2006, 12:57 PM

All this talk about trials is making me wonder, should all her2+ breast cancers get into trials? I am early stage, stage I, node negative, er/pr negative. I just completed chemo, 4 a/c, 33 rads, and doing herceptin for a year which began on Sept 11 of this year. I thought trials were only for those who have had reoccurences. Can someone shed some light on this for me please. Thank you.

Lolly · 10-26-2006, 03:11 PM

Hi Rinaina,
Depends on the trial criteria. Some are designed to accept early stager'ers, some late stager'ers. You could go to the trials page on this site (Joe has provided a link above), access the links provided, and start reading the criteria of the various trials!...Michele U who posted above is an early stage'er.

Barbara2 · 10-26-2006, 03:47 PM

I recently have had some correspondence with someone from the U of Washington regarding their vaccine trial. In order take part in this trial you need to be stage lll or IV. I don't understand why stage 1 or 2 are not included in these trials. It's been said that perhaps vaccines will be most useful for patients whose cancer is in remission, but who are high risk of relapse from minimal residual disease. Yet in order to be eligible for trials, studies, etc, you need to be in stage III or IV neihter of which are not considered an "early" stage of cancer. This doesn't make sense to me.

I thought perhaps I might qualify as I was less than 1/2 centimeter from a 5 cm tumor, which is considered stage III. I just sent off an email to Washington this afternoon with a few more questions, but I doubt that I will make the cut.

One of my questions to her was, how does the U of Washington vaccine trial differ from the one at Windber PA. I have read that there are two types of vaccine strategies currently being tested in patients with breast cancer:
1.Cell-based vaccines
2.Breast cancer antigen specific vaccines.

I asked her if she could tell me what the difference was between the vaccines these two facilities were offering. I believe the U of Wash uses a plasmid-based vaccine, GM-CSF. Windber's E75 vaccine is made from the Her2/neu proten, and GM-CSF. But what is the REAL difference? They are similiar sounding, but there's probably more to it than is obvious in the description. She will check into it and let me know.

Patients with breast cancer are encouraged to enroll in clinicl trials attempting to improve vaccine therapy. The criteria needs to be tweeked a little so more of us can get in........