Finally - a Vaccine Trial for me!

[StephN]

After years of not qualifying for any of the HER2 vaccine trials offered near my home, now there is one. It is the 133 at U of W Tumor Vaccine Group. It is a Phase I-II study, and just opened in August.

Passed all the screenings and got my first vaccine yesterday. This is a Peptide vaccine that has been tested in numerous trials before this, so what is new is the other agent given to try to boost the immune response ever further. That would be Ampligen.

This trial is open to stage IV BC patients as well, who are NED (me) or have stable bone mets. There is no allele or ANA requirement.

The vaccine is given in a split dose of 3 shots. Here are my weals! Only a bit red today, but no pain or itching.

[DeenaH]

Awesome! I am bound and determined to get into a vaccine trial too. I am hoping for NED in the near future. Do you get the TCell infusions too? Good luck!!

[KDR]

Stephanie,
I was so attracted to this trial and thyroid issues don't necessarily disqualify you, and nearly joined after conferring with Stephanie numerous times. I really hope that you have the results you deserve. I'm in New York and travelling to Seattle would have been tough, even with a best friend in Mukilteo.
Just wondering, why did you feel the need to be vaccinated at this point, with such a clean, stellar record?
My best wishes,
Karen

[Lauriesh]

Hi Steph, It is so exciting to hear you are in this trial. I am also. I will be flying to Seattle on Nov. 11 for my first round of shots.

I am a little nervous as I am stopping my Herceptin/tykerb for 4 months to do this trial. I have been NED since Feb., and am willing to risk it to see if this vaccine works.

Laurie

[Laurel]

Hurrah, Steph! For all who follow in your footsteps may I say, "thank you." I pray the results of the trial are positive in a massive way.

[michka]

Hi Steph. I am really happy you could start the trial because there is a lot of hope in vaccines. It is not the first trial so I figure they are getting closer and closer each time. It seems to me that after a small period of skepticism, research on vaccines is now central. Porte toi bien! Michele

[Ellie F]

Hi Steph
I have also enquired about this trial. It feels a bit scary on two counts, firstly way,way across the pond so I might need support from my her 2 sisters and secondly going without herceptin (most scary) for 3-4 months!
Really pleased that you finally got a trial. Keep us posted about how it goes.
Ellie

[NEDenise]

Steph!
Yay for you! Congratulations!
How cool that you even posted a picture, so we could celebrate with you!
You go girl! I wish you all the best! NED Forever!!!
Denise

[ElaineM]

I am very happy for you Steph. Congratulations for qualifying. Good luck with it. Let us know how it goes.
I want a vaccine in the future too. I check the U of W Tumor Group website for an updates from time to time.

[Mtngrl]

Steph--I'm very happy for you. Be sure to let us know how it goes.

[Jackie07]

Thanks for sharing. Hope you don't mind my posting that picture and the quotations in your signature on my FB. I know my nieces and nephews will be impressed (inspired)...

[caya]

Great news Steph!! We are pushing for the cure, and you are in the thick of it...

all the best
caya

[bejuce]

That is awesome, Steph! Having just finished a 6-month vaccine trial (MVA-BN HER-2 vaccine), I can only encourage you to pursue yours. I had no side effects with each shot besides a soreness/redness reaction at the site. I strongly believe in the vaccines and hope yours will keep you NED!

Keep us posted on the trial!

Marcia

[Pray]

Steph,Gods blessings to you Steph. That is wonderful news! I will pray it goes well for you. You are such a wonderful women who does so much good for so many of us on this site! This is your turn at haveing something great happen.Your Friend,Nancy

[jml]

StephN~
So excited for you!
And more than anything, feel such incredible respect & gratitude to you for pushing forward and supporting research, and continuing to always be so present & supportive to all of us here.
Thank you for all that you do and for your friendship here all these years<3

Jml

[Debbie L.]

Although vaccines have not (yet) shown much actual benefit, I hope and think that their time is approaching. Ideally, the success will be both from a treatment and a preventive perspective.

So I do have great hope for what the vaccine trials may do for those enrolled now, including you, Steph -- and for those to come. And I have great gratitude for all of you who've participated in the trials, over the years.

I had my intake appointment set, for a vaccine trial that was initiated out of the UofW, years ago -- when GSK canceled the trial. I would have participated at a site in the bay area (of California).

For me that trial would have involved the expense of a 5-hour drive, plus lodging, plus time ($$) lost from work. Which was not an insignificant expense for me. It was hard to consider taking that money away from the family, "just" for me, based only on my passion or intuition. But we could have managed it.

I have concerns about those who could not, in any way, manage such costs to participate in these kinds of clinical trials that involve travel. Especially the trials (like TDM-1) that might offer life-saving or life-prolonging advantages to those able to afford to access them. Yes, the trials themselves are "free". But the cost of travel and lost wages, especially nowadays in our tough economic climate, is prohibitive to many. Does anyone know of a clearing-house type of place (available nationally), where anyone (regardless of ability to pay) could get information about how they could be funded to participate in these trials? I know there are things like Angel Flights, and there are local or state organizations that offer assistance. But that involves a good amount of initiative and work on the part of the participant. Doesn't it seem like there should be easy-to-access, nationally-standardized opportunities for every person who wants to, to access a clinical trial? It's only fair and right.

It bothers me to think that some of these cutting-edge trials are available only to the rich, and/or to those who happen to live in cities that host the trials. We ALREADY, in the US, do not have equal access to quality care. It concerns me that the issues of travel costs and lost wages, for participation in trials, is widening that gap.

You'd think there would be a philanthropic organization out there who might want to step up to this plate, at least for breast cancer. Any thoughts?

Debbie Laxague

[StephN]

Lauriesh - I hope to meet you so let's keep in touch.

KDR - It is very easy for me to participate in this vaccine trial. I live about 20-25 minutes from the medical center and they cover the parking. If I plan a couple of errands on the way, I have not even used extra gas.

But the main reason is that I feel since I have been off Herceptin for alomost 3 years, that it is time to try something, since I am hormone negative and there is nothing else to take unless a tumor shows up someplace.

I do know of a woman who was HER2, stage IV, achieved remission PRIOR to Herceptin and was in an early vaccine trail here. She is STILL in remission. Who know exactly why, but they are studying her blood as well as mine to see what our natural HER2 immune response is. Something like 20% of us do have a natural reponse but it is usualy too low to fight a tumor. If I can boost my response to stay in remission, this is an easy route for me at this juncture.

Debbie L - I have met numerous women at the U of W who came for the previous vaccine trials. Many did have their airfare mostly or all paid by one of the organizations. Plus they had rooms in nice hotels at NO CHARGE and taxi vouchers from the medical center.

All they had to pay was a couple of meals.

Hope some of those gals will chime in.

[Ellie F]

Could somebody explain allele and ANA please?

Steph- is staying in Seattle very expensive? I stayed in Seattle in 1989 but with a friend from the Harbor view medical centre. She has since moved on so this is not an option now.

Debbie- totally agree with the cost issue. For me the flights from England would be very expensive especially if I have to go 3 times but like my sisters from other parts of the world we don't have the options for these types of treatments.

Thanks
Ellie

[KDR]

Debbie,
Any thoughts?

Yeah, Occupy The FDA.

Thanks,
Karen

[KDR]

Steph,
As you know, you (and Andi BB, Mamacze) are all what we want to be. So I wish you the best in this. We will be watching. My team has the utmost respect for Mary Disis. I suppose she is heaing the trial?
Warmly,
Karen

[Lauriesh]

Hi Debbie, as I mentioned earlier, I am also doing this trial, so I will be flying to Seattle four times.
I have found quite a bit of help with travel and lodging. Most is through the Amer. Cancer society. They provide one flight a calendar year, so 2 of my 4 flights will be free. They will also try to arrange free lodging. It is not guaranteed, as it depends on the city and time of year. but, if it is available, I can get free lodging all four trips. If I can't get lodging through them, there is an organization called Joe's house where you can get discounted hotels.
It didn't take too many phone calls/paperwork to get this help. After my first phone call to ACS, they e-mailed all of the possible resources, such as Angel Flights, Joe's house, etc. I hope no one decides against a trial because of expense, because there is a lot of help out there.

Laurie

[Jean]

Steph,
Sending you prayers and the very wishes!
Jean

[StephN]

Ellie -

An allele is a tiny part of our DNA and there was a certain one being targeted by one of the "DNA" vaccine trials. The HL allele was the target and it needed to be number 2. My HLA was number 26 on my DNA. It was a very specific blood test that took a couple of weeks to come back from a special lab. The current trials are not targeting specific DNA.

The ANA stands for AntiNucleicAntibody. It is an indicator of autoimmune disease, and in some people it can be positive in one test and negative another time. Mine was always positive, due to "we know not what."

The FDA has removed that restriction from the current vaccine trial.

Our member here, Full of Beans, came from the UK for a vaccine trial. She can give you some answers as to how she managed the flights and lodging. Another member came from New Zealand early this year, you can find her info under the Clinical Trials forum.
Hope this helps.

[Ellie F]

Thanks Steph for the explanation and advice.

My onc here has a lot of respect for the team at Seattle and was disappointed when I didn't qualify for an earlier trial due to prior use of herceptin. I also have a lot to thank them for! When I recurred my first onc stopped herceptin. However an onc there was reviewing my records for the trial and contacted me to tell me I MUST get herceptin back. I also got this advice from my sisters on the board.Needless to say I found a new oncologist!

Ellie

[StephN]

WOW, Ellie - I had forgotten that you were removed from Herceptin like that. The U of W Tumor Vaccine Group is deep into the study of anti-HER2 agents and are very aware of the POWER of Herceptin.

I believe a person can be taking Herceptin and paticipate in the current trials.

The 133 Vaccine trial is headed by Dr. Lupe Salazar and Dr. Disis.

[Joan M]

I recently checked out a vaccine trial at Sloan-Kettering, which was a DNA vaccine, but decided not to participate. The trial is being run by Dr. Gilewski who spent a lot of time explaining this phase I trial. The primary endpoints are immune response and safety. She is enrolling only 12 patients, and the trial started a few years ago at a low dosage. Two patients per dosage. Three dosage levels. She wanted to recruit me for the highest dosage, which is the last stage of the trial.

Dr. Gilewski also informed me about vaccine trials at U of Wash, but I had already checked into them. The U of Wash trial I was interested in had just closed to recruitment, but a new trial had just opened. Steph, that you're in the new trial. U of Wash e-mailed me those trial papers.

In terms of vaccines, I feel that I haven't been NED long enough and don't want to rock the boat. So, Steph, I understand how you might feel, since you've been NED a long time. I really aspire to that status! I'm so concerned about upsetting the apple cart, that when I left Sloan-Kettering recently for another group in NYC, I asked that my blood be tested every 9 weeks, rather than every 3 weeks when I have my Herceptin treatment. The onc was fine with that. But I had to ask. I wanted nothing to change. That frequency had been set up almost 4 years ago with my local onc, meaning in the first facility I received chemo for both early stage and advanced bc.

Joan

[Andrea Barnett Budin]

Dearest Steph, my Sister, http://cdn-cf.aol.com/se/clip_art/gstres/celebrte/fists

You've been through sooo much, and look at you now! You did it all with grace and courage, loving generosity, genuine caring and acts of kindness. You've become a wealth of knowledge and wisdom and -- we all love you.

I am right here, by your side. (Istopped Vitamin H in July 2008, as I KNOW you Know!) It is so great to be alive! I KNOW you Know this as well!! I say thank you for my life every single day.http://cdn-cf.aol.com/se/clip_art/peeps-emt/pple/clips/notworthy-clip

Thank you so much for sharing!

May you remain joyful, full of Life, inspirited and serene...

Please keep us all posted on your grand success story.
Sending you my love, as always,

Andi

[Andrea Barnett Budin]

Hi Joan,

I was looking at your avatar.

You did Herceptin for 1 yr? Off label?

When did you start H again?

I was confused and wondering.

I was on H for 10 yrs.

I tried to PM you but I am told your inbox is full. (Same happened to me once, I had to spend a while deleting...) Oh dear.

The I tried to e you, but a message comes up that the address you have listed is unknown.

So here I am talking to you the old fashioned way.



ANDI

[Joan M]

Hi Andi,

It's great to see you on the board again, and a relief to know that you're still doing well. You look wonderful!!

I took Herceptin off-label when I was diagnosed with early stage bc in September 2003. Since I had 7 positive nodes, I didn't want to risk drawing the arm in the Herceptin trial that didn't get the drug, so I didn't enter the trial. But my local onc agreed to give it to me off-label along with my other chemo (AC and Taxol).

The cancer advanced to the lung in early 2007, recurred in the lung in 2008, and spread to the brain in 2008. I've been NED since the brain surgery and 5 dosages of targeted IMRT radiation to the tumor bed. I have been only on Herceptin every 3 weeks since the cancer first spread because I had local treatments which removed each nodule. Adjuvant courses of chemo were offered after each procedure as insurance, but I decided against them. Sometimes I regret that, but I guess that's water over the damn.

Thanks for the heads-up on my PM in-box being full. I have to empty it out. I have to change my e-mail address also, as the one listed is incorrect.

Joan

[Ellie F]

Joan- I also looked into the trial with Dr Gilewski and my onc had numerous e-mail conversations with her. However I also decided against it, not quite sure why but it didn't feel right possibly due to the theoretical risk of contaminating my DNA with mouse DNA! Wouldn't want to grow whiskers and a tail, lol!
Ellie

[Andrea Barnett Budin]

Hey Joan!

Thanks for explaining. How great that your doc was willing to give H off label!

When I was orig dx (July '95) they weren't talking about HER2 gene. Then at my recurrence (Aug '98) it was in clinical trials and people were in desperate need of it. So the FDA fast-tracked H and it became available Sept. 28, 1998! I saw Herceptin as a blessing, though being dx w/a highly aggressive canser isn't exactly uplifting, for sure. I figured, at least they have something that stops that defective gene from overproducing!

I think each of us has at least one regret. I was told no radiation as I had a mastectomy/no breast tissue. But, it seems some had it even though... So in '98 I began second guessing.

Some of my oncs said since I had been orig ER borderline and put on Tamoxifen that that may have caused the metastasis, or -- being HER2+ (80% as they calculated back then) could have been the reason.

I keep looking forward. Told that what I had in '98 -- mets throughout my liver, too many to count -- was "incurable, inoperable, and that I would be on long term chemotherapy for the rest of my life.

I did 8 mnths of Taxotere, and w/a pleural effusion and peri-cardial effusion, water pouring out my eyes from the dryness, pain in every limb -- I just couldn't take 1 more treatment. To me, if I'd not been on my supplements (against most oncs' advice) during chemo, I wouldn't be here. They all helped keep my ejection fraction at 50 (down from 65%), kept my immune system fighting, fighting off free radicals, blah, blah.

And Herceptin (the "easy" chemo) became my long term chemotherapy.

After 10 yrs, I took the chance of going it alone, just me, my Spirit, and God.

My fav onc always says, if God-forbid I needed H, I can always return.

Steph is very brave moving forward w/the new vaccine. Now, I'm thinking...
Andi

[StephN]

Hi Everyone - Thanks for all your good wishes for this trial.

This is NOT the 6-vaccine series where you get back your Adoptive T Cells. It is a 3 vaccine trial with no aphoresis.

I misspoke earlier when I said 20 participants - it is FORTY in this phase.

Here is the link which I thought I also posted earlier (gee):
http://depts.washington.edu/tumorvac/trialclinical_133.php

You can all read about it and see that the Phase II will also be interesting as a second agent will be added to the Ampligen which I am getting. This means that the phase I am in is a dose determining phase for Ampligen. They already know the optimal amounts of the vaccine and the other immune boosting agent.

Stay tuned ... I am just trying to help research get to the next level here.

[Joan M]

Ellie,

I had the same thoughts!

Overall, we've come a long way in HER2 treatments since Andi's original diagnosis in '95.

Joan

[Elizabethtx]

Good luck Steph! Off you go blazing a trail. It to am beginning a vaccine trial in Tx this week. Not sure if it is the same one though. I'll post me details in a bit for all to see.
Elizabeth

[schoolteacher]

You are my hero.

Amelia

[krisvell]

Steph;
That is great news. May this Vaccine keep you NED forever.

[Debbie L.]

As always, such an interesting discussion. I appreciate the learning -- both about the relative ease with which people have found support ($$) to help them access trials, and about the many different trials and the details of them. Where else (but on this forum) could we hear so much about cutting-edge research and those who are helping to move it forward?!

Thanks to all!

I will add that I returned on Sunday from a project LEAD workshop in Seattle, where I had the pleasure to hear Lupe Salazar speak. Nora Disis was faculty at my first Project LEAD program in 2003. NBCC's Project LEAD programs always have strong faculty. Are you interested? They now offer two LEAD (science of breast cancer for advocates) formats -- a 2.5 day "workshop" for people to get their feet wet, and a 5-day "institute" which is more intense and delves much deeper. There is an international version, too -- it's not just limited to the US. It is an excellent opportunity both to learn more about breast cancer, to explore advocate opportunities, and to network with lots of amazing and wonderful women. I was going to post something about this when I first got back, but the NBCC website does not have the 2012 LEAD program schedule posted yet so I decided to wait. However, at the mention of Lupe Salazar, Nora Disis, and UofW, I am too tempted to chime in. Here's the website link but if you're interested, wait a bit and check back so you can see if there's a class that fits your schedule. http://www.breastcancerdeadline2020.org/learn/

Debbie Laxague

[StephN]

Thanks for posting - I did not even know about the Project LEAD workshop held here. Dr. Salazar almost bubbles over with enthusiasm on the work they are doing here and how far they have come with the research.

One of these years maybe my life will calm down enough that I can do something like that. I was at my mother's that weekend and a few more days.

Paty attended the meeting in Mexico earlier this year. She will be at SABCS. Stop by our table in the exhibit hall if you get the chance. Assume you will go?

[StephN]

Elizabeth - tell us how it is going with your vaccine trial. Do you come to Seattle or go elsewhere?

[CourtneyL]

Just wanted to add my congrats to you on joining the trial as well, Steph. You continue to be a source of inspiration and hope to me and so many of us here. May the vaccine help keep you NED forever!

[fullofbeans]

StephN glad that you can join that trial, may you stay NED forever indeed!

[Debbie L.]

Hi Steph, Yes, I'm going to SABCS and will look for you all. For the first time this year, I'm staying a ways out of town so will be coordinating schedules with my roommates and may not spend quite as much time at the convention center (like maybe not every waking moment, smile) as I usually do.

And I just got a PM from Paty from the LEAD forum site -- now I just have to figure out how to go there and answer her. Paty, if you're reading this here -- I look forward to talking to you, too!

And to get back to the topic of this thread -- it's great to hear all the vaccine trial participants talking about their experience. I hope you will continue to check in and educate us about the various approaches, the locations of the trials, and the logistical challenges that you've solved.

Debbie Laxague

['lizbeth]

Oh wow, my weals look totally different. I just popped up and saw you were in a vaccine trial. I am so happy for you.

I'm popping out to San Antonio in a few weeks for my next booster myself.

[StephN]

Hello -
Hope you are all enjoying this Thanksgiving weekend.

Thanks for all the discussion on this thread regarding the vaccine trials. This seems to be a very active area of research.

I had my second round last week (of a total of three - and no boosts). All is well. No flu-like symptoms at all - I think because the immune boosting agent works differently than what was previously used.

This is easier than getting Herceptin, and I hope it will help keep my immune system on high alert for any odd ball cells!

[norkdo]

congratulations steph on getting into this trial. you are doing so fantastic and u are a hero for the newly diagnosed like myself, who read your signature line.

[ElaineM]

I am glad you are doing well Steph. Keep up the great work.

[tricia keegan]

I also am so glad to read you're doing so well Steph and long may that last!!!

[StephN]

Reporting in that I had my last (of three) vaccines a couple of days ago and I feel just great. Since it is a trial and there are 4 doses of the immune booster being given, I don't know which one I am getting - the high, medium or low amount.

But I DO know I am getting some, just hope it is not the lowest amount as I have no side effects that I can tell.

Anyway, I go again for a blood draw in about 4 weeks and then again to give blood 11 months after that.

I met a woman who is coming all the way from Australia for this vaccine!

[Mandamoo]

Following with interest! There are no vaccine trials in Australia at all. It seems there is a lot of interest over there but whenever I speak to anyone here about it I am met with a mostly negative response. Let's hope that there is something magic in there for all of us - including the Stage 4 gals.

[StephN]

Hello Amanda -
The lady I met this week who is coming for the trial lives in the next valley over fom the Hunter outside Sydney. She said it was her oncologist who told her about the trial. So, there are some doctors who ar clued in about vaccines. The lady did not know about this web site.

Hope all is giong well with you. Are you still in the Bolero trial?

[Mandamoo]

Hi Steph - she comes from a beautiful part of our country then.
Yes - I am still on the Bolero trial - I have not really seen any reduction but I have now had 6 months of stable. I have had a partial response in my axilla node 21-13mm but not one of my lung mets has gone (they are small) or really changed. My skin met has also changed dramatically in appearance but it is still there and a little smaller. My onc has said if I hadn't had the positive biopsy on my skin she would wonder whether what the scans are showing in my lungs was actually cancer but given I had clear scans prior to my surgery in February and I am an otherwise healthy 39year old women there is little else to explain it. I tolerate the treatment very well now my dosage has been sorted and we think I am receiving the Everolimus so I hope to continue for quite some time yet.
The thinking behind the vaccine is just so appealing to me. Was there any talk about vaccines at San Antonio?
Amanda

[choyces]

Congratulations Steph!

I'm very excited for you. My paperwork for the trial is sitting on someone's desk at the UW. I'm waiting for the phone call. I will watch for your posts and how this goes for you. I hope to meet someday.

Tina

[StephN]

Hi Choyces -
Did you get into this vaccine trial?

I went today to give the first post vaccine blood draw - a BIG one!

Had some news from Dr. Salazar that they are suspending enrollment for a while - they have 28 right now.

They want to perform an interim analysis and find out which of the 4 doses of the Ampligen are giving immune response. The idea is that if there is a dose that is not effective they will stop that arm/arms and go forward with the rest of this phase after they analyze the first 24 of us for immune response.

They hope to let those of us who have had this combination know about our immune responses soon.

At this point the estimate to resume new enrollees is April sometime.

But anyone who is interested can contact the U of W Tumor Group and start the process.

[choyces]

Hi Steph,

I didn't get into Phase I of the 133 Vaccine trial. I have to be on herceptin for a year. They have my paperwork and have stated that if I stay in remission I will most likely be admitted into Phase II, which will start in about 6 months. I'm a little disappointed, but will continue with the herceptin. It's starting to give me some of the muscle aches others have reported. I'm continuing to walk and swim through it. I'm building a near infrared light box and canvas tenting system to turn my bath into a sauna. I expect this to help with pain and keeping my system clean.

I'm going back to my classroom in March!

Thank you for all the great information and please let us know how the trial is going for you and the other trailblazers.

Tina

[StephN]

Hay Tina-
I am sure the phase II version of this trial will be timely for you. After you have your year of Herceptin (believe me it IS worth it!), they second phase should be up and running. Just check with the coordinator when you get close to the end of your Herceptin.

Very enterprising of you to gin up the home made sauna! How is it working?

[StephN]

This trial (the 133 at U of W Tumor Vaccine Group) is back in action after a short break to catch up with the lab work. If you are interested, contact the U of W Tumor Vaccine Group soon as they are working through the waiting list right now.

[Mtngrl]

Thanks, Steph.

I live in Boston. I asked my oncologist to look into vaccine trials here. She said she would.

Keeping my fingers crossed for you!

[sarah]

Congrats Stephanie! this is great!!!
love
A+
sarah