Friday 14 December 2018

When trials change dramatically from their NCT descriptions

I was checking out https://clinicaltrials.gov/ct2/show/NCT01903330, "ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme".  It's a personalized cancer vaccine, but I can't find any mention of surgery on the NCT site aside from a mention of an injection. No mention of needing a tumor sample either.  If I'd been thinking, I should have been asking how they created the personal vaccine.

I called the program coordinator, and they told me there'd be surgery to get fresh tumor tissue to create the vaccine.  Plus you have to go in to them three times a week for three weeks, followed by a week off, then repeat.  All not mentioned on the NCT site.

The NCT site says that this is double blinded.  Given how everything else in the description seems to be different maybe this is no longer true.  Even if everyone gets the personal vaccine it's not worth the logistics for us (1-2 hour drive each way three times a week ugh).

There was a talk at the UCLA brain tumor conference last May about how a very small percentage of GBM patients take part in a clinical trial.  Not giving the potential trial participant good info doesn't help bring in more recruits.

2 comments:

  1. ERC1671 : The vaccine contains a combination of autologous tumour cells, and allogeneic tumour cells, generated from the glioma tumour tissues of three different donor cancer patients, and the lysates of all of these cells. Upon injection, this mixture stimulates the patient’s immune system to mount an immune response against the tumour cells, which may lead to their destruction.


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  2. This description is puzzling: who are the three donors and assuming they need to make thousands of vaccines who will their donors be? An autologous vaccine is primed with your own tumour lysate, not someone else's, is what I thought. They have been priming vaccines with certain peptides, but these peptides are well controlled. How can they control random donors and the peptides on their tumours?

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