CMLVAX trial

[Guest guest]

Thank you for posting this. Sounds very interesting. How often do you go to

Houston and what is the time commitment?

Thanks!

kisocean <kisocean@...> wrote:

Hi Group-- I travel to Houston for vaccine no. 4 in the trial cited

below. So far, no real side-effects. Everything is going just

swimmingly. An interesting note-- I've noticed a reduction in the

" Gleevec fog " I've been experiencing so long.

Leukemia Vaccine Looks Promising

Vaccine Boosts Body's Attack on Cancer Cells

By Jeanie Lerche

WebMD Medical News Reviewed By Brunilda Nazario, MD

on Thursday, February 17, 2005

Feb. 17, 2005 - An experimental vaccine could provide a new treatment

for people with chronic myeloid leukemia (CML), a new study shows.

Not only does the vaccine boost the body's immune system to fight

leukemia, but it also helps get rid of the underlying cause of the

leukemia. Currently, this can only be done with a bone marrow transplant.

This could help lead to a cure for CML, which affects about 4,500

Americans each year.

In chronic myeloid leukemia, overproduction of an abnormal protein

leads to very high numbers of cancerous white blood cells.

Current treatment, such as Gleevec, targets this abnormal protein.

Although Gleevec normally gets rid of any detectable cancer cells, the

cancer-causing protein still remains.

And that's what researcher Bocchia, MD, a hematologist with

Siena University in Siena, Italy, wanted to address. Her study appears

in this week's issue of The Lancet.

The researchers tested the use of a cancer vaccine to help trigger the

body's immune system to recognize and attack cells with the CML protein.

Cancer vaccines are not vaccines in the way that most people think of

vaccines. Unlike most vaccines, which help prevent diseases, cancer

vaccines are added to treatment in someone who already has cancer.

In her study, she and her colleagues recruited 16 patients with

chronic myeloid leukemia. All had received treatment with either 12

months of Gleevec or 24 months of interferon alpha, another CML

treatment. The patients' disease was stable.

Each was given six injections two weeks apart. The vaccine actually

contained the abnormal protein itself. This stimulates the immune

system to launch an attack against cancerous cells containing the

abnormal protein.

Nine Gleevec-treated patients showed progressive reduction of their

remaining disease. Five patients went into complete remission; three

had no evidence that the CML protein was still lurking. All but one of

the six interferon-alpha-treated patients had a good response; two

went into complete remission.

The researchers say the vaccine was effective at stimulating an immune

system attack against the cancer cells with the abnormal protein.

They say adding the vaccine to current CML treatment may help get rid

of remaining cancer cells.

In addition, the vaccine was able to get rid of the cancer-causing

protein -- a sign that the CML has been cured.

The vaccine is experimental and not yet available to the public.

SOURCES: Bocchia, M. The Lancet, Feb. 19, 2005: vol. 365, pp. 657-662.

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[Guest guest]

Hello

I am so pleased to read about your experience with this trial and the

lessening of your 'gleevec fog'. My 23 year old son has cml and this

is really good news and gives much hope for the future for all of

those with cml.

I dont know the circumstances of you joining this trial, but

nevertheless want to send you a really big THANK YOU! for doing so,

as this will also bring my son one step, or many steps, closer to a

cure.

I will follow this closely and hope you post again, keep us updated

with how you are doing, please.

With sincere wishes for success for you and enormous thanks for what

you are doing.

Love and light

Annie

's mom

www.livingwithcml.blogspot.com

>

> Hi Group-- I travel to Houston for vaccine no. 4 in the trial cited

> below. So far, no real side-effects. Everything is going just

> swimmingly. An interesting note-- I've noticed a reduction in the

> " Gleevec fog " I've been experiencing so long.

>

> Leukemia Vaccine Looks Promising

>

> Vaccine Boosts Body's Attack on Cancer Cells

> By Jeanie Lerche

> WebMD Medical News Reviewed By Brunilda Nazario, MD

> on Thursday, February 17, 2005

>

> Feb. 17, 2005 - An experimental vaccine could provide a new

treatment

> for people with chronic myeloid leukemia (CML), a new study shows.

>

> Not only does the vaccine boost the body's immune system to fight

> leukemia, but it also helps get rid of the underlying cause of the

> leukemia. Currently, this can only be done with a bone marrow

transplant.

>

> This could help lead to a cure for CML, which affects about 4,500

> Americans each year.

>

> In chronic myeloid leukemia, overproduction of an abnormal protein

> leads to very high numbers of cancerous white blood cells.

>

> Current treatment, such as Gleevec, targets this abnormal protein.

> Although Gleevec normally gets rid of any detectable cancer cells,

the

> cancer-causing protein still remains.

>

> And that's what researcher Bocchia, MD, a hematologist with

> Siena University in Siena, Italy, wanted to address. Her study

appears

> in this week's issue of The Lancet.

>

> The researchers tested the use of a cancer vaccine to help trigger

the

> body's immune system to recognize and attack cells with the CML

protein.

>

> Cancer vaccines are not vaccines in the way that most people think

of

> vaccines. Unlike most vaccines, which help prevent diseases, cancer

> vaccines are added to treatment in someone who already has cancer.

>

> In her study, she and her colleagues recruited 16 patients with

> chronic myeloid leukemia. All had received treatment with either 12

> months of Gleevec or 24 months of interferon alpha, another CML

> treatment. The patients' disease was stable.

>

> Each was given six injections two weeks apart. The vaccine actually

> contained the abnormal protein itself. This stimulates the immune

> system to launch an attack against cancerous cells containing the

> abnormal protein.

>

> Nine Gleevec-treated patients showed progressive reduction of their

> remaining disease. Five patients went into complete remission; three

> had no evidence that the CML protein was still lurking. All but one

of

> the six interferon-alpha-treated patients had a good response; two

> went into complete remission.

>

> The researchers say the vaccine was effective at stimulating an

immune

> system attack against the cancer cells with the abnormal protein.

>

> They say adding the vaccine to current CML treatment may help get

rid

> of remaining cancer cells.

>

> In addition, the vaccine was able to get rid of the cancer-causing

> protein -- a sign that the CML has been cured.

>

> The vaccine is experimental and not yet available to the public.

>

> SOURCES: Bocchia, M. The Lancet, Feb. 19, 2005: vol. 365, pp. 657-

662.

>

[Guest guest]

Hi Margot and group--

I am enrolled in " A Pilot Phase ll Trial of a Synthetic Tumor-Specific

Breakpoint Peptide Vaccine in Patients with CML and Minimal Residual

Disease " It's also referred to as the CMLVAX trial.

There are several ongoing trials for CML going on at MDACC. I am #11

in this study. The goal is to learn whether giving CML-VAX B2--that's

mine--or CML-VAX B3 together with Gleevec 400 mg can decrease or

eliminate all evidence of disease in patients who are CCR, but who

still have low levels of residual disease. I think they are still

enrolling--maybe nine more patients--at MDACC. The trial is also

ongoing at MSKCC and OHSU.

If you are within driving distance of Houston and not yet CCR, this is

a trial to consider. It requires a lot of travel for me. I fly to

Houston from Los Angeles. You must travel to Houston for a -30

evaluation, and more test requiring a 2-3 day stay at -2. On day 0 you

receive the first of 15 vaccines. You must travel to Houston once

every two weeks for the first eight weeks. Once again 3 weeks later

and then once a month for a total of 15 vaccines in 12 months. Two

days before each vaccine injection you self-inject leukine (GM-CSF),

and you also receive another dose of leukine just before the vaccine.

The side effects, for me, are minimal. Mostly just transient redness

around the site of the injection.

I fly in early in the morning, have blood tests and the vaccine, have

a quick lunch, then back to the airport.I BMA is performed several

times during the year. I think that I'm up for my next one in August.

I've copied some information about the various vaccine trials from

MDACC below. If you are interested in Joining up, contact Cortes

at MDACC:

Vaccines and Other forms of Immunotherapy

Immune modulation may be partially responsible for the favorable

results with IFN- & #945;. Immunomodulation with vaccines in CML is

attractive (table 3). Different types of antigens may be used in CML

vaccines. One approach is to use tumor-specific antigens. The Bcr-Abl

fusion creates a new sequence of amino acids only expressed in

leukemic cells. Short peptides containing 8 to 12 amino acids, derived

from the fusion region, have been tested. In a phase II trial, by Dr.

Sheinberg and his group at Memorial Sloan Kettering, 14 patients

received a mixture of 6 fusion peptides: 4 patients had a decrease in

Ph-positive cells while continuing IFN- & #945; therapy (n=3) or

imatinib (n=1); 3 treated for molecular relapse after stem cell

transplant had a transient complete molecular response (2 had

concurrent DLI).28

Using a similar approach, Bocchia et al in Italy vaccinated 16

patients with stable residual disease after at least 12 months of

imatinib therapy or 24 months of IFN- & #945; therapy with a

CML-specificp210-b3a2 peptide. Among the 10 patients treated with

imatinib, 5 of 9patients with residual Ph-positive metaphases achieved

a completecytogenetic response, and 3 had undetectable levels of

Bcr-Abl by PCR.Of the 6 patients treated post IFN- & #945; therapy, 5

improved their cytogenetic response (2 achieved complete cytogenetic

response).29

A different peptide used for immune stimulation is PR1, a nonapeptide

derived from proteinase 3 and presented through HLA-A2.1. Proteinase 3

is expressed in myeloid cells during normal neutrophil maturation and

is overexpressed in myeloid malignancies. Cytotoxic T-lymphocytes

(CTL) specific for PR1 inhibit colony formation in an HLA-restricted

manner. PR1-specific CTL are identified in most patients with CML who

responded to IFN- & #945; or allogeneic SCT, but not in non-responding

patients or in patients treated with chemotherapy. In one study, 10

patients with CML were treated with PR1:1 achieved a complete

cytogenetic response, and 3 had cytogenetic improvement.30

T-cell cytotoxicity might be particularly important in generating an

immune response that can eliminate residual leukemia. A new cell

therapy approach to treatment of CML is also being investigated. The

strategy is based on the use of lethally irradiated, thus

non-proliferating, clonal human T-cell line with MHC non-restricted

killer activity against a broad range of tumors. The cell line,

TALL-104, can lyse tumors across several species while sparing cells

from normal tissues.

There are several studies ongoing with vaccines for patients with CML

at M.D. , some in collaboration with many other centers in the

USA. These include:

1) Studies of CMLVAX (junction peptide vaccine) in patients with

Ph-positive CML who have received at least 12 months of therapy with

imatinib and are in complete cytogenetic remission but have stable or

increasing levels of BCR-ABL as determined by realtime PCR.

2) Studies of PR1 vaccine in patients with Ph-positive CML who are

HLA-A2 positive who have received at least 12 months of therapy with

imatinib and are in complete cytogenetic remission but have stable or

increasing levels of BCR-ABL as determined by realtime PCR.

3) A study of TALL-104 for patients with CML who have failed or have a

suboptimal response with matinib therapy.

For information on immune modulation studies, please contact Dr.

Cortes or any other leukemia physician.