On the Risks of Clinical Trials

Caring Bridge - July 1, 2019:

Asher was admitted to inpatient care today, due to low potassium levels, high CO2 levels, and very high glucose. The potassium levels are possibly due to much of the vomiting from the previous week. The CO2 levels are likely due to his poor breathing. High glucose is potentially linked to the clinical trial he is participating in. His blood pressure has also been a little high. Please pray that his blood chemistry and vitals can be brought under control.

I’ll preface this commentary by stating very clearly that I have a deep love and respect for the doctors and researchers at St. Jude. No highlighting of the risk of cancer research are in any way meant to reflect poorly upon them, or to imply that my son’s quality of life was somehow secondary to the advancement of cancer research.

In the land of a making thousand decisions in a short period of time, there’s a weight to signing paperwork to sign up your terminally ill child to participate in a clinical trial. It could be a miracle. Finding cures has to start somewhere, right? It could also directly or indirectly make things worse. So there’s an additional element of trust you are placing in those conducting research.

Asher and his fellow DIPG/DMG patients participated in a clinical trial to determine the maximum tolerated pediatric dose (MTD) for GDC-0084 (Paxalisib). If you read the conclusion of the study, you’ll see that they did arrive at an MTD that is 80% of an adult dosage. You’ll also see that at the concluding dose of 27 mg, “Grade 3 hyperglycemia was the only DLT” (dose limiting toxicity. In other words, it was like giving the patient (a child) diabetes. Some patients were even put on a common diabetes drug, Metformin, in order to combat this particular side effect.

At the time I wrote this post on Caring Bridge, Asher was in a particularly bad state as he had entered into ketoacidosis territory. In triage just prior to being admitted, his playfulness was noticeably absent. My boy was very sick and it showed.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7650438/