Encouragement needed to decide whether to join a vaccine trial

[bejuce]

Hi everyone,

I've been thinking of joining a vaccine trial for a while now that I've been off Herceptin since July. This trial here is currently recruiting patients at Berkeley, CA, and I'm pretty much almost all set to join it. I was hoping to do it at Stanford, but my oncologist has moved on to Genentech and the trial was discontinued there.

I'll have my first consultation at Alta Bates on the 18th, to sign the consent forms, get my labs done, be examined, and do a chest ray and echo. The next step is to perform an apheresis to I think extract some cells to be used in the engineering or analysis of the vaccine. One of the concerns I have is that the nurse told me over the phone that they'll have to use both my arms for this procedure, including my right arm under which I removed 13 lymph nodes. I still have my port in place hoping for exactly this - that I'd be able to use for a vaccine trial. Since I won't, sounds like it's time for me to get rid of it after all.

I'm strongly leaning towards joining this trial, but before I do so, I'd like to hear from those of you in vaccine trials elsewhere how you're dealing with their side effects and so on. The vaccine I'll be taking consists of a fixed monthly dose for a 6-month period - no major side effects have been reported.

My main concern with this is whether the vaccine won't backfire and instead of slowing tumor progression or prevent its recurrence, it'll actually stimulate its growth. Not sure if that's possible, so those of you (Lani?) that are much more versed in the biological sciences and understand it, can you please offer me your two cents? I'm basically looking for that extra pinch of courage to move forward and not look back and regret my decision.

Thank you in advance for your input and hope that 2011 will be a year of many successes and good news for all of us!

Marcia

[michka]

Hi Marcia. I am moving your post back up since nobody answered and you are asking for encouragement. I do not know what advice to give you since I know little about vaccines. I hope someone can tell you if it could do you harm because if the risk is only that it may work, then your decision may be easier to make. Michka

[Debbie L.]

Hi Marcia,

I think that only you can make this decision. It sounds like you have not yet done the full consenting process? They will go over possible side effects in detail (perhaps more detail than you care to know, smile). This is a small phase I study -- the earliest kind of study, where the least is known both about efficacy and safety. I'm curious why you chose this study over others -- can you tell us about that?

I think that so far, there have been no concerning issues with the vaccine trial side effects. There are some theoretical concerns, and lack of longterm safety data which is of course the case with almost all clinical trials. I have not heard any concerns about cancer vaccines increasing cancer growth, as you mention. Regarding effects on the cancer, the issue so far has been the lack of clinical success from all these trials -- so it's a lot of time and effort on everyone's part (including patients), with a return of more information but not the clinical benefit we'd hope for. But maybe now is the time to be doing this -- maybe the vaccine tide is ready to turn (I sure hope so). There have been several small cancer vaccine studies reporting positive results recently. I keep meaning to go back and find the poster I saw at SABCS that had a positive report. But no time today.

Keep us posted. I hope others who know more will chime in here. And I'll throw out a concern, not about vaccine trials but about trials in general: what do you all think about the fact that access to trials, and to expanded access (such as TDM-1) is limited by a person's ability to afford the travel and other expenses? Unless of course you happen to live in a city and that city happens to be a trial location. I can see for a wee trial (20 people) like Marcia is considering, that it's impractical to expect it to be available more broadly. But for the larger ones, with locations all over the country yet still not not available locally for most -- I see a big access disparity issue here and have not heard much talk about it. Your thoughts? We can take it to its own thread if anyone want to talk about this.

Debbie Laxague

[AlaskaAngel]

10 cents from far-flung Alaska....

Treatment as a relatively rural Alaskan gave me some perspective about this, so I'll pass it on.

For the most part, when talking about urban vs rural, one tends to think in terms of rural people having to drive long distances to get there, and stay in a motel during each active testing portion of a trial.

For Alaskans it is often more of a question of having to do all of that by boat or plane just to get standard treatment.

After treatment, because my cancer center was in Seattle, I took the opportunity to investigate trials offered there, and eventually persuaded a trial coordinator to include me in one that I have been doing for 7 years now. As part of that trial I have an annual transvaginal ultrasound done only on-site in Seattle, plus blood draws periodically both during that one visit each year as well as in Alaska and sent on dry ice to Seattle. So... It sometimes can be done, although it is not easy or simple. I pay for all draws done in Alaska.

Other trials ARE more difficult. I participated in one offered by the Mayo clinic by traveling on my own dime to their facilities in the Lower 48 for the initial verification that I met their criteria plus a physical, and then did the blood draws in Alaska.

What it takes is determination and personal dependability to follow through, as well as some exceptional cooperation from trial coordinators, plus the participation and verification by one's local PCP, and it only happens for trials where the on-site function is not essential throughout the trial for site-standardized scientific authentification purposes.

A.A.

[Ellie F]

Debbie- would be really grateful for any posters you can find about vaccine trials.

Marcia- I have also been looking at vaccine trials. My onc is supportive but not convinced of their efficacy.My reservations are similar to yours about stimulating an immune response that has negative consequences! I guess the decision has to be yours and is not an east one to make. I hope Debbie is able to post some positive results.

Ellie

[Debbie L.]

Okay, thanks for the nudge, I'd been meaning to go back and look at this in more detail. Small study (50-ish in this booster group), short follow-up, and not really statistically significant efficacy results except in the boosted group and issues with them (more ERPR- and Herceptin there). But still, I was impressed. Hard not to notice ZERO recurrences. I can't figure out how to link directly to the PDF download. It's on this page:

http://www.posters2view.com/sabcs10/...&#session_PO37

There may be a log-in required, if so it's just a matter of saying you want to be a guest and accepting their terms. (Since I logged in to get to that page, I can no longer tell if it will work as a direct link, argg.) If the link doesn't take you straight there, you'll choose "enduring materials/posters" from the column on the left, then click on the 2010 conference under "posters2view", then choose "friday" from the days at the top, and scroll about halfway down to the "Treatment - Therapeutic Strategies: Immunotherapy (Clinical)", then it's the first one - 20-01.

And then there's the abstract which is here:
http://www.abstracts2view.com/sabcs1...=SABCS10L_1299

Phew!

Debbie

[bejuce]

Thank you all for your responses! I have an appt scheduled for the 18th to find out more about the trial and I'll let you know how it
goes. I'm willing to try it out as it is close to where
I live and it was the vaccine that my oncologist had been working on and has so much faith on. Not sure I there are any other research results reported in the literature besides the ones I posted, but I'll find out.

I discussed joining this trial with Dr. Slamon back in October (albeit not in too many details) and he encouraged me to do so saying
that although nothing has been proven yet about the vaccines, it wouldn't hurt.

For more info on the vaccine, you can google MVA-BN HER-2.

Thanks!

Marcia

[krisvell]

Marcia;
I am 1/2 way through a Vaccine Trial in Washington DC. While I can't weigh in on whether the one you are looking at is a good one, I can share with you how I decided to go for it. There were two trials that I qualified for and I chose the Walter Reed one because the side effects were not significant and it was a Phase II Trial and it didn't mention any terrible things that could happen to you. The sucky part is it's a randomized trial so I only have a 50% chance of getting it. I rationalized it was worth the time and travel expense to help others down the road. Some very brave ladies did that for us with Herceptin. The other trial I seriously considered; a DNA vaccine at Sloan mentioned there was a slight chance Herceptin could be rendered ineffective in the future. Although it was remote, it scared me. 'Lizabeth and Sandra from GA did the vaccine and gave me great insight and support. My sister in law is a cancer researcher and thought it was a good idea; couldn't hurt. I know someone (Kim) on this site who did a vaccine at the Univ of Washington and has been in remission a very long time in NED after having mets to the liver and lungs; Great Inspiration. After I decided, I met a lady who's also doing the vaccine; she's an OB/GYN and thinks it's worth it.
Oh Yeah; I found a youtube video from a Dr. at Brooke Army Medical Dr. who presented phase I results from the Trial.
I am not at all technical to understand the detail but my common sense is what led me to decide.
You'll know if it feels right. Feel free to contact me if you need any additional information. Good luck; you'll make the right decision.

Kris...

[anna4969]

Hi Everyone,

I am quite new here but read many of the informative posts and feel like I have educated myself immensely on this site. Thank you.

I just started a vaccine trial at MD Anderson last week Monday. It is actually an offshoot of the Walter Reed Trial but the difference being I am getting the GP2 + GM-CSF while still on Herceptin. I will have 6 vaccines and possibly boosters. I am not too sure about the boosters as I am only in the beginning of this trial. I met with the principal investigator in December and was very impressed and hopeful by her research. So far so good, but as I said I just started.

My oncologist, at my home hospital, reminded me that vaccines are not proven yet, but it certainly couldn't hurt. Interestingly, he is the one who told me about this trial but I think he just didn't want me to think this was a miracle drug. He did think it wise to take the vaccine approach rather than another drug that might damage tissues. That being said, it seems to me that all of the results on the few vaccines out there have proven to be very safe. In terms of it's effectiveness in stopping recurrences, I think it might be too soon to know. So far though, I sure like what I see.

I am so pleased to be doing this vaccine. If anyone has questions, I would be happy to share my experiences thus far.

[bejuce]

Thank you for all your support. I went to Alta Bates yesterday, met with the research nurse and the doctor, and signed the consent form. The first step is to do an apheresis (which I'll do on the 8th) and then I'll have 6 shots of the vaccine (given monthly). With each shot, I'll have my blood work done and towards the end of the trial I'll have another apheresis to determine whether I had an imunological response to the vaccine.

One thing I'm happy about is that the oncologist there will run the CA 15-3 tumor marker test for me. I have not had a tumor marker test done before as my oncologist doesn't believe in it, but this oncologist uses it on a regular basis.

The trial still has 5-6 spots open, so if anyone would like to sign up, feel free to send me a PM if you need more details. I'm expected to have no major side effects, except maybe slight irritation at the vaccine site.

[krisvell]

Marcia;
Congratulations! Please keep us posted on the trial. I'm very interested to compare notes. I got for my 4th one on Monday (01/24). It goes by fast. Hopefully you don't have to travel as far as I do.

Good luck on your 1st vaccine.

Kris...

['lizbeth]

Bejuce

Just found your posts about the vaccine trial. I am so thrilled that you decided to enroll. I am in the booster part of one of the Walter Reed vaccine trials. Good luck. I had side effects with mine, but overall started to feel much better. Chemo had kicked my a**. I think the vaccine & GMSF helped my immune system recover.

['lizbeth]

@kris - you do receive a small amount of the vaccine twice if you are in the control arm of the Walter Reed trial. Once in the beginning to see if you have ever been exposed to the peptide, and 6 months later to see if your immune response has improved.