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Medical Forum / Diseases and Disorders / Cancer / February 2008

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Stimuvax (L-BLP 25), Vaccine in development for non-small cell lung     cancer

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Irishgirl - 13 Feb 2008 03:01 GMT
Has any one here been involved with testing of a new drug called
Stimuvax (L-BLP 25), It is a vaccine in development for non-small cell
lung cancer

My moms doctors are talking to her about trying this, I don't like the
idea. To me is like gambling with her life . She is not sure if she is
getting the drug or not for the testing of this new medications.

Can anyone share their experience, thoughts or opinion about using a
medication still testing. I don't want to loose my mom because of a
bad choice.

Thank you!
Irish girl
J - 13 Feb 2008 10:05 GMT
> Has any one here been involved with testing of a new drug called
> Stimuvax (L-BLP 25), It is a vaccine in development for non-small cell
[quoted text clipped - 7 lines]
> medication still testing. I don't want to loose my mom because of a
> bad choice.

I suppose that's one way to know if it makes a significant diference or
not.
The other way would be the investigational drug vs placebo, but no chemo.
I think Penny's (SCLC) was like that and she quit, when her cancer was
progressing. She did not know which arm (treatment or placebo she was on)

But then if you want the tumor, in her throat to shrink, the chemo is the
best chance of doing that (without as many side effects of RT? - a
radiation oncologist would have to say on that).
J
http://www.medicalnewstoday.com/articles/42498.php
Final Phase 2b Survival Results Of Stimuvax(R) Trial In Patients With
Non-Small Cell Lung Cancer
Date: 29 Apr 2006
The controlled, open-label Phase 2b trial enrolled 171 men and women with
NSCLC whose disease was stable or who had responded to treatment following
completion of their first-line standard chemotherapy with or without
radiation therapy. Patients were randomized to either Stimuvax(R) plus
best supportive care or to best supportive care alone. Best supportive
care includes palliative radiation therapy and/or second line chemotherapy
according to current standard clinical practice. The study was designed to
document the safety profile of the vaccine and to evaluate efficacy by
comparing survival in the two arms.

An earlier survival analysis reported in November 2004, indicated that the
median survival in the pre-stratified subset of locoregional Stage IIIB
patients on the vaccine arm had not been reached. Informal survival
results from an additional exploratory analysis have now been confirmed
showing a median survival in the Stage IIIB patients on vaccine being 30.6
months, while the Stage IIIB patients on the control had a median survival
of 13.3 months.

Stimuvax(R)
Formerly known as BLP25 Liposome Vaccine (L-BLP25), Stimuvax(R) is a
synthetic MUC1 peptide vaccine. Stimuvax(R) incorporates a 25-amino acid
sequence of the MUC1 cancer mucin, encapsulated in a liposomal delivery
system. The liposome enhances recognition of the cancer antigen by the
immune system and facilitates better delivery. Stimuvax(R) is designed to
induce an immune response to cancer cells.

Looks like she would still be receiving Cyclophosphamide aka Cytoxan?
http://www.cancerhelp.org.uk/help/default.asp?page=11226
BLP 25 lung cancer vaccine is still not a proven treatment for people with
non small cell lung cancer.  Until we have results from larger trials, the
best treatment for non small cell lung cancer is still surgery,
radiotherapy and chemotherapy, depending on the stage of the lung cancer.

A larger phase 3 trial called START (stimulated targeted antigenic
responses to NCSLC) has now started to recruit.  It will recruit about
1,300 people with stage 3 non small cell lung cancer  from various
countries around the world.

It is a randomised trial. The people taking part will be put into
treatment groups by a computer. Neither you nor your doctor will be able
to decide which group you are in.
As with the earlier trial, everyone taking part will have standard
treatment.
Two out of every three people taking part will also have stimuvax vaccine
injections. And 1 out of every 3 will have dummy (placebo) injections. You
have injections once a week for 8 weeks, and then once every 6 weeks after
that.
http://clinicaltrials.gov/ct/show/NCT00409188 (has the trial details)

i searched on it at http://www.lchelp.org/ Message board, but it was just
talk about it. One person wanted to get in on a trial, but the next scan
showed he was now Stage IV, so was no longer eligible.

Another place to ask would the ACOR mail list
http://www.acor.org/mlists/mlists.html
Click on L for Lung, then NSCLC to join.
You could ask your question, then unsubscribe later, if you wish.
The trial seems to have started July 2007, so there may be people, or
their loves ones there who've been in the trial.
So you could ask to hear their experiences. If it's on a blog or in their
signatures, that might help, so ask for those.

There's so many forums on the www for cancer support, unfortunately, it's
difficult to get them all to one place, so there'd only be one place to
ask.

I know you want the best for your mother. Good luck in helping her with
her decisions.
Keep in touch.
J
Irishgirl - 13 Feb 2008 10:41 GMT
> > Has any one here been involved with testing of a new drug called
> > Stimuvax (L-BLP 25), It is a vaccine in development for non-small cell
[quoted text clipped - 88 lines]
> Keep in touch.
> J

J

Thank you so much for reaching out to me again, You are a wealth of
information and a real angel.  Mom had a MRI last week and seen the
oncologist today, the good news is there was no sign of the tumor in
her chest.The chemo has helped, I am so happy and grateful

However they have approached her with participating in the trials.
She is still very sick. She wants me to go with her to talk with the
doctors about the new treatment. Ultimately it is her decision, but I
am so afraid of her not getting everything she possible can to fight
this, We had some really good days this week though. She has started
to let her guard down, not trying to do this all by herself.  She is
letting us go with her more and I am thank for that.

I have been reeading all night everything I could find, however I was
not finding a actual patients opinion yet, I am continuing to dig.  I
appreciate the new leads

I will keep you posted and again Thank you! Thank you! Thank you!

Irishgirl

ps Do you mind if I ask you are you a patient or in the medical feild ?
J - 14 Feb 2008 10:02 GMT
> ps Do you mind if I ask you are you a patient or in the medical feild ?

I'm not a current cancer patient.
I am not in the medical field, but did want to be, so studied most of my life.
J
J - 14 Feb 2008 10:10 GMT
> > > Has any one here been involved with testing of a new drug called
> > > Stimuvax (L-BLP 25), It is a vaccine in development for non-small cell
[quoted text clipped - 26 lines]
>
> I will keep you posted and again Thank you! Thank you! Thank you!

You're welcome, Irishgirl.
I'm happy to hear she got a great response to her treatment.
I'm pleased to read that you'll be going with her.
Ask her if she has questions; write them down and leave spaces for the doctor's answers.
(Some people fax them ahead of time)
Write the answers down for her so she can concentrate on his input and possible subsequent questions.
Keep in touch and letr us know how it's going, please.
And take care of you (and your needs) as well.
J
J - 20 Feb 2008 00:29 GMT
ishgirl wrote:

> Has any one here been involved with testing of a new drug called
> Stimuvax (L-BLP 25), It is a vaccine in development for non-small cell
[quoted text clipped - 7 lines]
> medication still testing. I don't want to loose my mom because of a
> bad choice.

I think you should start with which type of breast cancer your mother has.

I think Steph told us that almost every reoccurence is chemo-resistant.
Your mother must have paperwork saying which type of breast cancer she
had?  Perhaps she was too old (or has other health problems) for some of
the type of medicines (due to risks) and that's why they're looking at
clinical trials.

Stimuvax and Theratope seem to have been developed by Biomira,
but Therahope is not mentioned on their web page.
http://www.biomira.com/clinical/stimuvax.html
I've found references to both around 1997 and 1999 - clinical trail or
"promising" news items.
FDA fast tracked Theratope for ER+ breast and ovarian cancer
Stimuvax failed for prosate cancer
The trial for Theratope was paused and restarted.
I find numerous places where they're saying it failed.
<http://www.conversationsincare.com/news/releases/archive/2003/2003_06_17.html

Merck got involved with this product.
I've seen mention of reformulation, but cannot remember if it was before
the anouncement of the merge or acquisition.
Nor if it was beforee (or after) the announcements of failures.

Clinical trials have to be repeated in order to avoid bias. Phase I and II
still check for safety .
Some products prove to be no better than water (or placebo). Some aren't
quite as good as a standard and some are better. Many prove to be no
better than placebo. A clinical trial is for science - to answer the
questions.

If your mother does not have insurance or has to pay a large co-pay for
medicines, maybe that's why she's interested in clinical trials?

So many company names, so many name changes; difficult to find a clear
picture.

Neither have been mentioned by patients on any of the cancer newsgroups
(other than a few inquiries years ago, on other newsgroups).

There's 1,000's or more clinical trials for BC, so why he picked that one,
I don't know.
I'll continue to look for information. Let us know, what you find out,
please.
J
 
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