Glivec + Zileuton at UMass

[Guest guest]

Hello All,

This is Info that was posted on Jerry Mayfield's site recently about the UMass

trial. Recently Jerry asked Dr Cerny a series of questions. Below are the

questions, and Dr Cerny's response.

http://www.newcmldrug.com/Discuss/default.asp

Healing thoughts to all of you,

Don

==========================================================

Hi Dr. Cerny,

I have been following this research since it was published about a year ago. It

is very exciting stuff, indeed. I hope that the mouse models used in the study

translate into human response.

I am pleased that you, as the principal investigator of this trial, have offered

to answer our questions and I welcome you to our discussion group.

Can you tell us something about the protocol? For example: How often would

patients be required to come to the trial center? What test will be performed on

trial patients? What will be starting doses and what is the escalation schedule?

Which are you going to use, Zileuton, ZyFlo or ZyFlo-CR along with Gleevec? How

will you monitor stem cell response?

Thank you for your efforts to find the cure that we have all been hoping and

praying for. I hope we can help you to fill the trial slots rapidly.

Regards,

Jerry

========================================================================

Hello everybody,

here are some answers (to Jerry's questions) that I can share with you at this

time. We are evaluating the safety profile of the combination (Z+I) and finding

the right dose (most therapeutic effects and minimal side effects).

So initially patients are planned to be seen at least every two weeks (it may be

more often based on the patient's needs). But the frequency of visits also

depends on the dose level of zileuton at which a particular patient was

enrolled. Once we make sure that the combination is tolerated without

significant side effects, the intervals for visits will extend. We do not want

to disrupt the standard treatment (with imatinib) and we aim to do everything

including visit schedule as close as possible to what it would be without being

on the study (if we can).

Tests: standard blood tests (cell counts, chemistries etc.) to assess side

effects also blood for Q-PCR. BM at entry and then either as per standard of

care or as needed based on individual situation. Standard evaluations with

cytogenetics/FISH and PCR.

We will use the short acting drug and I can envision changing it to the long

acting one if no side effects are present in the future.

Besides the standard tests we will ask for extra blood or bone marrow samples

(whenever these would be scheduled so no extra procedure, but little extra

volume). We will use these samples for evaluation of the response by our

research assays. Some of these methods have not been published, yet so I can't

share them with you at this moment.

Once again I am preparing a website, which will soon be open and will have some

of this information. Thank you Jan C.

[Guest guest]

Hi All.

I have a neighbor who is a scientist and works for Novartis. She asked me if I

knew of which top doc who treats CML was offered to head a new lab to be built

in Mass. Does anyone know?

Sandi

>

> Hello All,

>

> This is Info that was posted on Jerry Mayfield's site recently about the UMass

trial. Recently Jerry asked Dr Cerny a series of questions. Below are the

questions, and Dr Cerny's response.

>

> http://www.newcmldrug.com/Discuss/default.asp

>

> Healing thoughts to all of you,

>

> Don

>

>

> ==========================================================

>

> Hi Dr. Cerny,

>

> I have been following this research since it was published about a year ago.

It is very exciting stuff, indeed. I hope that the mouse models used in the

study translate into human response.

>

> I am pleased that you, as the principal investigator of this trial, have

offered to answer our questions and I welcome you to our discussion group.

>

> Can you tell us something about the protocol? For example: How often would

patients be required to come to the trial center? What test will be performed on

trial patients? What will be starting doses and what is the escalation schedule?

Which are you going to use, Zileuton, ZyFlo or ZyFlo-CR along with Gleevec? How

will you monitor stem cell response?

>

> Thank you for your efforts to find the cure that we have all been hoping and

praying for. I hope we can help you to fill the trial slots rapidly.

>

> Regards,

> Jerry

>

> ========================================================================

>

> Hello everybody,

> here are some answers (to Jerry's questions) that I can share with you at this

time. We are evaluating the safety profile of the combination (Z+I) and finding

the right dose (most therapeutic effects and minimal side effects).

> So initially patients are planned to be seen at least every two weeks (it may

be more often based on the patient's needs). But the frequency of visits also

depends on the dose level of zileuton at which a particular patient was

enrolled. Once we make sure that the combination is tolerated without

significant side effects, the intervals for visits will extend. We do not want

to disrupt the standard treatment (with imatinib) and we aim to do everything

including visit schedule as close as possible to what it would be without being

on the study (if we can).

> Tests: standard blood tests (cell counts, chemistries etc.) to assess side

effects also blood for Q-PCR. BM at entry and then either as per standard of

care or as needed based on individual situation. Standard evaluations with

cytogenetics/FISH and PCR.

> We will use the short acting drug and I can envision changing it to the long

acting one if no side effects are present in the future.

> Besides the standard tests we will ask for extra blood or bone marrow samples

(whenever these would be scheduled so no extra procedure, but little extra

volume). We will use these samples for evaluation of the response by our

research assays. Some of these methods have not been published, yet so I can't

share them with you at this moment.

> Once again I am preparing a website, which will soon be open and will have

some of this information. Thank you Jan C.

>

[Guest guest]

Hi Sandi,

This was posted on Jerry Mayfield's (birthday boy today) site the other day

after Dr Jan Cerny (Chief Investigator) posted some info on

the trial. I don't know if how he fits into the overall picture but has been

quite enthusiastic in sharing information. Let me know if I you would like me

to further research this for you. I have a very good rapport established with

Dr Cerny.

Warmest,

Don

====================================================================

Dear Jerry,

My friend Dr. Jan Cerny here at UMass Medical School told me about this " CML

Talk " website, and I took a look at it during my lunch time today. I am amazed

by your discussions about CML and the Alox5 story with other people, thinking

that I could have invited you for discussions of my future research at our lab

meetings. I have to say that the reason for me to join in with your website

discussion is that I found that some interpretations of the Alox5 gene and

related findings in my lab are not absolutely accurate; without giving specific

examples, I would suggest that you should feel free to ask me

(shaoguang.li@...) to join you with your discussions when necessary.

Another reason for having me could be that we have some exciting unpublished

novel discoveries related to Alox5 and Zileuton in my lab, and I may be able to

make some useful comments to help you to understand the science behind the

trial. Anyway, I will try my best to make comments, but I believe that Jan would

be able to communicate with you more frequently than I do.

Best,

Shaoguang

====================================================================

> >

> > Hello All,

> >

> > This is Info that was posted on Jerry Mayfield's site recently about the

UMass trial. Recently Jerry asked Dr Cerny a series of questions. Below are

the questions, and Dr Cerny's response.

> >

> > http://www.newcmldrug.com/Discuss/default.asp

> >

> > Healing thoughts to all of you,

> >

> > Don

> >

> >

> > ==========================================================

> >

> > Hi Dr. Cerny,

> >

> > I have been following this research since it was published about a year ago.

It is very exciting stuff, indeed. I hope that the mouse models used in the

study translate into human response.

> >

> > I am pleased that you, as the principal investigator of this trial, have

offered to answer our questions and I welcome you to our discussion group.

> >

> > Can you tell us something about the protocol? For example: How often would

patients be required to come to the trial center? What test will be performed on

trial patients? What will be starting doses and what is the escalation schedule?

Which are you going to use, Zileuton, ZyFlo or ZyFlo-CR along with Gleevec? How

will you monitor stem cell response?

> >

> > Thank you for your efforts to find the cure that we have all been hoping and

praying for. I hope we can help you to fill the trial slots rapidly.

> >

> > Regards,

> > Jerry

> >

> > ========================================================================

> >

> > Hello everybody,

> > here are some answers (to Jerry's questions) that I can share with you at

this time. We are evaluating the safety profile of the combination (Z+I) and

finding the right dose (most therapeutic effects and minimal side effects).

> > So initially patients are planned to be seen at least every two weeks (it

may be more often based on the patient's needs). But the frequency of visits

also depends on the dose level of zileuton at which a particular patient was

enrolled. Once we make sure that the combination is tolerated without

significant side effects, the intervals for visits will extend. We do not want

to disrupt the standard treatment (with imatinib) and we aim to do everything

including visit schedule as close as possible to what it would be without being

on the study (if we can).

> > Tests: standard blood tests (cell counts, chemistries etc.) to assess side

effects also blood for Q-PCR. BM at entry and then either as per standard of

care or as needed based on individual situation. Standard evaluations with

cytogenetics/FISH and PCR.

> > We will use the short acting drug and I can envision changing it to the long

acting one if no side effects are present in the future.

> > Besides the standard tests we will ask for extra blood or bone marrow

samples (whenever these would be scheduled so no extra procedure, but little

extra volume). We will use these samples for evaluation of the response by our

research assays. Some of these methods have not been published, yet so I can't

share them with you at this moment.

> > Once again I am preparing a website, which will soon be open and will have

some of this information. Thank you Jan C.

> >

>