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