Hi to all,
I've received and update concerning the Zileuton (600mg) + Glivec (400mg) Phase
I trial taking place at UMass, Amherst, MA. After a phone call from Dr Cerny discussing the current status of his trial, he followed-up with an email. He also informed me during our phone conversation that the other four participants are doing fine, and expects approval to continue soon. I think he told me This phase I trial will eventually have 15 participants.
I've already received some excellent inquires from members of the other CML Boards. Like, is this a cure? Do you have to continue Glivec after the trial? How is a "cure" going to be measured, etc. I've sent off another email to Dr Cerny asking these questions. I'll follow-up as I receive updates from either Dr Cerny (Lead Investigaor) or Dr Li (Lab Director).
The trial is based on data in an article published in NATURE GENETICS VOLUME 41 NUMBER 7 JULY 2009 titled "Loss of the Alox5 gene impairs leukemia stem cells and prevents chronic myeloid leukemia"
Here is a link to the article:
http://newcmldrug.com/Discuss/Alox5_gene.pdf
***As Dr Cerny states in his email, please, please do not trial this on your own at home***
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Dear Mr. Adkins,
thank you for "reminding" me (Dr. Li actually) that I have not gotten back to
you. My apologies! We have open the trial and have recruited first few patients.
One of the patients have developed possibly related grade 4 toxicity. We have to
follow stopping rules of the trial and also our IRB rules. We put the accrual
of new patients on hold. Hence some of you may have noticed the change on the
website. We are awaiting the word from safety monitors (or DSMB). My plan is to
continue with the study as soon as possible, I will let you know. I am greatly
touched by all of your support and interest in this research. I am as anxious as
everyone else and can't wait for all the results. But I want to make sure that
we can proceed safely with accrual of new patients. Unfortunately, we have to
wait.
**I would also strongly recommend that nobody tries this treatment "at home". As
much as we want to find cure, we want to make sure it is done safely and
everything is recorded.** Sometimes small nuances make a big difference. That is
why we have to do clinical studies under research protocol. Now to your second
point/question, I have asked personnel from our development office to open an
account for our research. This fund would serve as an assistance to patients who
e.g. need long distance travel. Our resources are at this moment limited to the
clinical and laboratory research related expenses.
Thank you very much for your inquiry, I will be happy to make a follow up phone
call.
Jan Cerny, MD, PhD
Assistant Professor of Medicine
Division of Hematology/Oncology
Department of Medicine
University of Massachusetts
55 Lake Avenue North
Worcester, MA 01655
Tel.: 774-442-3903
Fax.: 774-443-7890
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Healing thoughts to all,
Don
