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Alert Number 235

“Vaccine Therapy” Clinical Trial at Baylor

Date: May 27, 2007

There has been a flurry of recent interest in chat rooms about the so-called “Vaccine” clinical trial at Baylor College of Medicine, Houston, under the guidance of Dr. Malcolm Brenner. I have corresponded extensively with Dr. Brenner a couple of years ago when this trial was just getting started, and I made a point of attending their presentation at the ASH 2004 conference. Even the presenter described the bottom line as “the good news and the bad news”, trying to put a good spin on the results I suppose – not exactly a rousting celebration of success. The link to our report form the ASH 2004 Highlights is presented here for your convenience: Gene Therapy Revisited.

Don't you just love how the names change, as these clinical trials move from one establishment to the next?  It was the “Gene Therapy” when CD40 ligation came to our attention first, back in 2002-2003 at UCSD. A lot of people waited breathlessly for this trial, with as much anticipation as I would have for the arrival of Dr. Beverly Crusher of Star Trek's Enterprise. We saw a high profile plenary article on the Phase I results, then a long period of silence as the less-than-wonderful Phase II results were digested — and no indication there will ever be a Phase III version of the “Gene therapy”.  

We next heard of a slightly different version of the CD40 ligation therapy, migrating to M. D. Anderson along with Dr. Bill Wierda as he moved from UCSD to M. D. Anderson. This time, it was given the more cryptic name “MDACC Protocol 2004-0914”, using “ISF35”. Try sorting that one out! It needs a glutton for detail to follow the technology and identify the common threads.

Now we have the “Vaccine Therapy” at Baylor. It has pretty much the same scientific underpinnings as the earlier Gene Therapy, with a few more bells and whistles added. What makes this a vaccine, why is this also not a gene therapy? Your guess is as good as mine. But you have to admit, titles such as “Gene Therapy” and “Vaccine Therapy” have a wonderful space age, high-tech flavor to them. Patients can dream of low toxicity, marvelous curative potential, nothing short of the proverbial free lunch that is just outside of our reach. But do remember this is a phase I clinical trial, as as with all phase I's its principal purpose is to establish safety and dosage, not to offer therapeutic benefit to the participants.

The devil is in the details, folks. Ask questions first; make sure you are comfortable you understand what you are getting into, before you sign on the dotted line. I am a great believer in truly informed consent. Clinical trial participants are brave volunteers to be admired, not suckers sold on a sexy label. I would be the last person to discourage anyone from participating in a clinical trial. How else would we ever get new and better therapy options for our patients? I just think the process should be a bit more transparent and respectful: perhaps then there would be a little less chance of you buying a pig in a poke.

Be well,



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