Vaccine Clinical Trials
 

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

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

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,

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

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.

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

Brian
 

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

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

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

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

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

Regards
Joe

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.

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

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!

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

Viral Vaccine
 

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

Trovax
 

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

Which trial to participate in at U of W?
 

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

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.

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.

University of Washington/Windber PA
 

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........

Vaccine Categories
 

When looking at these various vaccine trials, notice that there are various categories of the type of vaccine. Some are DNA based, some are going for another target. The U of W has at least three vaccine trials and those who post here have been in at least two different trials.
The confusion is easy to understand.

The latest one not yet out will be TROVAX (virus based), about which Lolly posted my last post. It is not yet available, and my med onc said not until after the new year does she expect to have it to offer her patients. This vaccine will not be limited to breast cancer patients, so is taking longer to get through all the approvals.

When communicating with Patty Fintak, try to be specific about what you are aking about. If you give her some basic info she can tell you which trial you should be looking at.

Just wondering still about trials
 

I am curious as to whether or not early stagers who have no history of reoccurences or metastisis' at all ever qualify for any trials or is it only those who have had reoccurences or metastisis'? I am all about doing whatever one can to help research as well as ourselves and I know once I complete Herceptin I will probably go through an anxious period of "NOW WHAT"!

Rinaina, they will take stage III patients, which is not cancer that has metastisized. They also take stage IV, metastasis.

I am in the "What now?" stage and very much wish they would accept the lower stages of cancer.

Keep an eye out for Phase III on these trials, at that point they'll probably be taking early stager'ers.

rinaina
 

I think the Windber trial is available for early stage patients similar to you.

The question which someone else might be able to answer is whether they have started the trial which allows the patinet to be on/to have had Herceptin as well.

If you want to read the early results google PubMed and put in Peoples G (for George Peoples the principal investigator of the trial) The Windber trial and the Walter Reed trial are the same, it is just you have to be military related to get into Walter Reed, as I understand it

Hope this helps

Bringing up a very old thread. What is the status of these vaccine trials now, and are there still vaccine trials open?

Ruth by size of original tumor would be stage 3. Is there anything else we should be looking at, now or after Herceptin one-year is over?

THX all

vaccines
 

does any one know if Canadians can partake in v-trials in the US?

for those who missed my post on the E75 trial on 2/7/08
 

for those following or participating in the E75 her2 vaccine trials at Walter Reed/PA
the 2008 version of the results are in and they are not as positive as the 2006 SABCS interim report--So stop reading if you don't want to know...

It seemed more in the vaccinated group recurred than in the control group

Glass half empty/glass half full--1)the immunity seems to wane with time, so they are now gearing up to give booster shots and hope this will help 2) the were unsure of the most efficacious dose/scheduling and perhaps the results will improve as more get a more efficacious dose 3) these are small numbers with larger trials perhaps more of the variables which caused these results will become clear 4) they are uncertain of the role of HLAB2/3 in this (a requirement to get into the vaccine arm of the trial) but think HLAB2 positivity itself may increase the rate of recurrence. Trial numbers with HLAB3+s are still small, but results initially seem similar.

What seemed weird to me is how they could put such a positive "spin" on their abstract and the end of their conclusion section. Yes, they hope the results will improve with booster shots, more patients getting better doses, unravelling the relationship with HLA B3/4, but that is just speculation it would seem.

1: Clin Cancer Res. 2008 Feb 1;14(3):797-803.
Combined Clinical Trial Results of a HER2/neu (E75) Vaccine for the Prevention of Recurrence in High-Risk Breast Cancer Patients: U.S. Military Cancer Institute Clinical Trials Group Study I-01 and I-02.

Peoples GE, Holmes JP, Hueman MT, Mittendorf EA, Amin A, Khoo S, Dehqanzada ZA, Gurney JM, Woll MM, Ryan GB, Storrer CE, Craig D, Ioannides CG, Ponniah S.
Authors' Affiliations: Department of Surgery, General Surgery Service, Brooke Army Medical Center, Fort Sam Houston, San Antonio, Texas.
PURPOSE: E75 is an immunogenic peptide from the HER2/neu protein, which is overexpressed in many breast cancer patients. We have conducted two overlapping E75 vaccine trials to prevent recurrence in node-positive (NP) and node-negative (NN) breast cancer patients. EXPERIMENTAL DESIGN: E75 (HER2/neu 369-377) + granulocyte macrophage colony-stimulating factor was given intradermally to previously treated, disease-free NP breast cancer patients in a dose escalation safety trial and to NN breast cancer patients in a dose optimization study. Local and systemic toxicity was monitored. Immunologic responses were assessed using in vitro assays and in vivo delayed-type hypersensitivity responses. Clinical recurrences were documented. RESULTS: One hundred and eighty-six patients were enrolled in the two studies (NP, 95; NN, 91). Human leucocyte antigen A2 (HLA-A2) and HLA-A3 patients were vaccinated (n = 101), whereas all others (n = 85) were followed prospectively as controls. Toxicities were minimal, and a dose-dependent immunologic response to the vaccine was shown. Planned primary analysis revealed a recurrence rate of 5.6% in vaccinated patients compared with 14.2% in the controls (P = 0.04) at a median of 20 months follow-up. As vaccine-specific immunity waned over time, the difference in recurrence lost significance at 26 months median follow-up (8.3% versus 14.8%); however, a significant difference in the pattern of recurrence persisted. CONCLUSIONS: E75 is safe and effective in raising a dose-dependent HER2/neu immunity in HLA-A2 and HLA-A3 NP and NN breast cancer patients. More importantly, E75 may reduce recurrences in disease-free, conventionally treated, high-risk breast cancer patients. These findings warrant a prospective, randomized phase III trial of the E75 vaccine with periodic booster to prevent breast cancer recurrences.
PMID: 18245541 [PubMed - in process]



"Overall, the vaccinated patients were at higher risk for recurrence than the observed patients. More patients in the vaccine group were steroid hormone receptor negative and not on hormonal therapy. HLA-A2 has previously been implicated as a negative prognostic factor in ovarian (30) and prostate cancer (19, 31), and our results here extend this concept to breast cancer.

At our primary analysis, there was a statistically significant difference in recurrence rates between vaccinated and observed patients. However, this statistical finding did not extend out to 26 months due to additional recurrences, including a vaccine patient that recurred at 58 months. We have documented that E75 immunity wanes over time with only 48% of patients maintaining significant residual immunity at 6 months. As a result, a booster program has been initiated. Additionally, these are mixed trials with a total of seven different dose groups. Only one of the eight recurrent vaccinated patients received what is now determined to be the optimal biological dose of the vaccine. Interestingly, a difference in recurrence pattern was observed between the control and vaccine patients. Fifty percent of the observation patients had bone-only recurrences consistent with published rates (32–34), whereas no vaccine patients had bone-only recurrence. This surprising finding is being further investigated. Although there was a higher incidence of visceral metastases among vaccinated patients, the death rate was substantially lower, further suggesting a potential clinical benefit to the vaccine.

Although the E75 peptide has been exclusively tested in HLA-A2+ patients (50% of the population), additional data suggest that E75 binds HLA-A3+ (15% of the population; ref. 21). We extended the E75 vaccine to HLA-A3+ patients, and the toxicity profile, DTH reactions, and recurrence rates were similar to HLA-A2+ patients. This suggests expanded use of the E75 vaccine in HLA-A3+ patients, therefore addressing two-thirds of the general population with a single-peptide vaccine.

These data show that E75 is safe and effective at stimulating a HER2/neu-specific immune response and may prevent recurrence. These intriguing findings should be confirmed in a randomized, controlled phase III trial, enrolling only HLA-A2+ and HLA-A3+ patients."