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Old 09-11-2006, 08:13 PM   #1
Christine
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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?

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Old 09-11-2006, 09:06 PM   #2
Lolly
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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
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Old 09-11-2006, 10:10 PM   #3
sherri
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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,
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Old 09-12-2006, 09:36 AM   #4
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Where do we find info about the trial? Do they accept stage 1?
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Old 09-12-2006, 12:42 PM   #5
michele u
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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.
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Old 09-12-2006, 01:21 PM   #6
Julie2
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I finished all the three vaccines of the DNA trial in UW. Going for followup checkup
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Diagnosed in Sept 2004 while pregnant with the second child. Stage 3b, tumor 4.5cm, 4 auxillary and supraclav node positive. Her2+++ FISH 9.4 and er-,pr-.
Had dose dense neoadjuvant AC,Taxol then mastectomy,radiation+xeloda+Herceptin.
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Old 09-12-2006, 01:51 PM   #7
Brian
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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
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Old 09-12-2006, 10:11 PM   #8
michele u
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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
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Old 09-12-2006, 10:17 PM   #9
DonnaNY
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Could you please tell me how to contact Patty Fintak? Thank You!
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Old 09-13-2006, 06:53 AM   #10
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To access clinical trial information, just go to our clinical trials page:

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

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Old 09-13-2006, 08:25 AM   #11
Cynthia
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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.
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Old 10-26-2006, 08:54 AM   #12
amccreery
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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
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Old 10-26-2006, 12:57 PM   #13
rinaina
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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.
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~Rina~
Dx:3/06 had a lumpectomy April 19, 2006
Her2+ er/pr- Stage I Grade 3 tumor size 1.4 cm, node negative
AC 4 dense doses
34 radiation treatments including booster doses
receiving herceptin every 3 weeks since late August 2006 for 12 months
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Old 10-26-2006, 03:11 PM   #14
Lolly
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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.
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Old 10-26-2006, 03:47 PM   #15
Barbara2
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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........
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Blessings and Peace,
Barbara

DX Oct 02 @ age 52 Stage 2B Grade 3 Mastectomy
"at least" 4.5 cm IDC 1+node ER+61% /PR-
Assiciated Intraductual component with Comedo Necrosis
Her2+ FISH8.6 IHC 2+
5 1/2 CEF Arimidex
Celebrex 400mg daily for 13 months
Prophylactic mastectomy
Estradiol #: 13
PTEN positive, "late" Herceptin (26 months after chemo)
Oct 05: Actonel for osteopenia from Arimidex.
May 08: Replaced Actonel with Zometa . Taking every 6
months.

Accepting the gift of life, I give thanks for it and live it in fullness.
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Old 10-26-2006, 05:41 PM   #16
StephN
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Wink 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.
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"When I hear music, I fear no danger. I am invulnerable. I see no foe. I am related to the earliest times, and to the latest." H.D. Thoreau
Live in the moment.

MY STORY SO FAR ~~~~
Found suspicious lump 9/2000
Lumpectomy, then node dissection and port placement
Stage IIB, 8 pos nodes of 18, Grade 3, ER & PR -
Adriamycin 12 weekly, taxotere 4 rounds
36 rads - very little burning
3 mos after rads liver full of tumors, Stage IV Jan 2002, one spot on sternum
Weekly Taxol, Navelbine, Herceptin for 27 rounds to NED!
2003 & 2004 no active disease - 3 weekly Herceptin + Zometa
Jan 2005 two mets to brain - Gamma Knife on Jan 18
All clear until treated cerebellum spot showing activity on Jan 2006 brain MRI & brain PET
Brain surgery on Feb 9, 2006 - no cancer, 100% radiation necrosis - tumor was still dying
Continue as NED while on Herceptin & quarterly Zometa
Fall-2006 - off Zometa - watching one small brain spot (scar?)
2007 - spot/scar in brain stable - finished anticoagulation therapy for clot along my port-a-catheter - 3 angioplasties to unblock vena cava
2008 - Brain and body still NED! Port removed and scans in Dec.
Dec 2008 - stop Herceptin - Vaccine Trial at U of W begun in Oct. of 2011
STILL NED everywhere in Feb 2014 - on wing & prayer
7/14 - Started twice yearly Zometa for my bones
Jan. 2015 checkup still shows NED
2015 Neuropathy in feet - otherwise all OK - still NED.
Same news for 2016 and all of 2017.
Nov of 2017 - had small skin cancer removed from my face. Will have Zometa end of Jan. 2018.
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Old 10-30-2006, 12:57 PM   #17
rinaina
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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"!
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~Rina~
Dx:3/06 had a lumpectomy April 19, 2006
Her2+ er/pr- Stage I Grade 3 tumor size 1.4 cm, node negative
AC 4 dense doses
34 radiation treatments including booster doses
receiving herceptin every 3 weeks since late August 2006 for 12 months
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Old 10-30-2006, 08:58 PM   #18
Barbara2
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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.
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Blessings and Peace,
Barbara

DX Oct 02 @ age 52 Stage 2B Grade 3 Mastectomy
"at least" 4.5 cm IDC 1+node ER+61% /PR-
Assiciated Intraductual component with Comedo Necrosis
Her2+ FISH8.6 IHC 2+
5 1/2 CEF Arimidex
Celebrex 400mg daily for 13 months
Prophylactic mastectomy
Estradiol #: 13
PTEN positive, "late" Herceptin (26 months after chemo)
Oct 05: Actonel for osteopenia from Arimidex.
May 08: Replaced Actonel with Zometa . Taking every 6
months.

Accepting the gift of life, I give thanks for it and live it in fullness.
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Old 02-11-2008, 09:02 PM   #19
TSund
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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
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Terri, spouse of Ruth, Dallas/Ft. Worth area
Ruth dx 05/01/07 (age 50) Filipino
multifocal, several tumors .5 -2.5 cm, large area
Breast MRI showed 2 enlarged nodes, not palpable
100%ER+, 95%PR+, HER2+++
6x pre-surgery TCH chemo finished 9/15/7 Dramatic tumor shrinkage
1 year Herceptin till 6/08
MRM 10/11/07, SNB: 0/4 nodes + Path: tumors reduced to only a few "scattered cells"
now 50% ER+, PR- ???
Rads finished 1/16/08
Added Tamoxifen,
Finished Herceptin 05/08
NOW is the time to appreciate life to the fullest.
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Old 02-12-2008, 08:48 AM   #20
mimiflower07
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vaccines

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