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Both ketoconazole and posaconazole are FDA-approved anti-fungal agents with a well-known side effect and safety profile. In vitro studies, Ketoconazole and posaconazole have demonstrated effectiveness in reducing tumor cell proliferation. Posaconazole has a more predictable half-life than ketoconazole and has less off-target effects as a drug. As a first step, a demonstration of sufficient penetrance of study drug in brain and tumor tissue, as well as biological effects prior to large scale clinical trials is needed. The investigator will also look at pharmacodynamic differences, as this report will include a total of five control participants. Adding a control group to this research rather than both the samples means that the investigator believes posaconazole may be a more promising drug for moving forward. Plasma drug concentration measurements are unreliable way to determine drug delivery across the blood-brain barrier. In comparison, intracerebral microdialysis catheter testing of the brain allows for approximate measurements within extracellular fluid sampling of the brain. MDC placement within the brain is not a novel approach, and it has been used routinely in the ICU to monitor brain function by sampling ECF of traumatic brain injury patients. The dialysis probe has a semipermeable membrane that is less than a meter in diameter, which is fused into two sections of microcatheter. Previous studies have shown the possibility of keeping the catheters in place of critically ill patients for up to two weeks.
Source link: https://clinicaltrials.gov/ct2/show/NCT04869449
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