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
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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
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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.