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Gleevec + Zileutin at UMass

Hi Everyone,

I inquired about this trial and got the following information:

I received a call from Dr Jan Cerny at UMass. We talked for a lengthy amount of time about how the trial was going to work and when it was going to start.

They have one patient enrolled in the Phase I trial and plan on ramping up to 15. They plan on starting everyone one on a minimum dose of Zileuton and 400 mg (I guess they are assuming standard dose) of Gleevec and monitor every two weeks. As the patient shows tolerance for the drugs, they will increase to a medium dose. They will continue to monitor and if the patient shows tolerance for the medium dose, they will increase to the maximum dose. They will stop the patient at the level they can tolerate.

Patients will be monitored by PCR's and other methods (don't know what they are but they must be new and awaiting patents). The concentration level of the drugs will be monitored for each patient.

You will not be required to do a BMB unless it is your annual (or whatever time period you have agreed to with your local onc), or you request one.

Dr Cerny's team is already in discussion about testing Spycel (and other TKI's) and Zileuton as the next step. Of course they have to prove their concept first with Gleevec.

Dr Cerny has agreed to post information to the CML Discussion boards if the owners approve. I've asked Jerry and he said to press on so you should see some more info from him soon. He will be calling me back in a couple of days to see if their is a continuing interest.

Sandy, please let me know your thoughts on Dr Cerny posting to this site.  I know and understand that many are sensitive to medical personnel being privy to their private conversations, so I will continue to be the conduit for any trial information if you so desire.

I hope this information is useful.

Warmest regards,
Don

Don,

I found this link the other day.  Is the trial linked to these findings?

http://www.bangordailynews.com/detail/108012.html

Dear Don,

Thank you for sharing this news with us here.  This forum is in fact open to all and can be viewed by anyone who chooses to visit the site. However in order to post, registration is needed and that is the only restriction - apart from rules governing data protection. However, in general health professionals do understand that the discussion forums are primarily for the support and sharing of information between patients and caregivers.  If you are happy to do so, I think it would be best for you rather than the trial investigator, to continue to update us as and when you receive information about this trial. 

Thanks again for you willingness to share this news with the global CML community

Best.... 

Sandy ;o)

 Hi Ian.... yes it is the same drug. The article was written last year on 16/10/09 so things have obviously moved on, which is good news.

Best wishes,

Sandy

“The power of this strategy is for curing the disease, not just controlling it,” Li said.The gene, called Alox5, allows leukemia-producing stem cells to develop and proliferate, Li said.In research at The Jackson Laboratory, Li studied mice that had been specially bred to lack the Alox5 gene.“If you remove the gene from a mouse, you don’t see leukemia develop,” he said. That’s because Alox5 is somehow tied to the development of cancer stem cells, the precursors to leukemia, he said.

Li also studied normal mice with leukemia, targeting the Alox5 gene with the drug Zileuton, which is approved for treating asthma. Zileuton successfully blocked the gene’s production of an enzyme that turns cancer stem cells into full-blown leukemia cells.“When you block the gene’s function by using the drug … you’re going to be leukemia-free,” Li said.

Mice treated with a combination of Zileuton and Gleevec, the most effective treatment currently available for chronic myeloid leukemia, fared even better than mice treated with either medication alone. Li said Zileuton must now be studied in human clinical trials before it can be prescribed for leukemia patients. “A lot of patients will be interested” in participating in those trials, he forecast.     “This is for a cure."

 

Thanks Sandy, I will continue to provide the information that I get.  Dr Cerny is calling me back tomorrow with an update so I will pass on whatever info I get.  Ian, Sandy is correct, it is the same.


For those of you whom are more scientifically minded, here is a link to an interesting read:

http://www.unav.es/ciencias/estudios/doctorado/articulos/Naturegenetics0...


Everyone have a great day and stay positive!


Warmest regards,

Don