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Alert Number 139
Date: December 9, 2024
Not long ago we reviewed an exciting new clinical trial using 17-AAG, an analog of Geldanamycin, a natural antibiotic produced by by the bacterium Streptomyces hygroscopicus. This new drug shows promise in blocking ZAP-70, the proliferative driving force behind CLL. The new trial had opened at Ohio State University, and I understood it was going to be a multi-center trial with other institutions participating in it as well down the road. You can refresh your memory by clicking on the link: 17-AAG Clinical Trial.
It has come to my attention that the trial has been suspended. One of our members saw the suspension notice by clicking on the link at the official government clinical trials website: NCT00098488. I wrote Dr. John Byrd, the principal investigator for the trial at OSU and he was kind enough to reply promptly. Below is his response, published with his permission:
All of the NCI sponsored 17-AAG studies were suspended temporarily to include additional cardiac monitoring. This is because there have been a few cases of prolongation of QT interval on EGK analysis following treatment with this agent. There have been no untoward cardiac events in patients receiving this to my knowledge. Dr. Percy Ivy is the officer at the NCI who supervises this agent. Overall, we are very excited about this drug as a single agent and in combination with other agents because it targets so many important survival proteins in CLL.
While the suspension of the trial is disappointing news to us, I am nevertheless encouraged that extra care is being taken to monitor cardiac function of volunteers in this clinical trial, to protect them as far as possible from potential risk. In prior articles on our website we have questioned other clinical trial protocols that seem to short-circuit some of the necessary screening procedures in the interest of expediency. We are all grown ups here and we do understand most cancer drugs come with the price of some level of toxicity. But that does not give researchers a free pass to forgo prudent and careful monitoring of patients participating in clinical trials.
We hope the issues related to 17-AAG will be resolved soon and the trial resumes.
Be well,
Chaya
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