Glioma Clinical Trial
Official title:
An Early Phase 1 Trial of Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma
The primary aim of this study is to determine the presence of gemcitabine in childhood diffuse midline gliomas (DMG) (previously classified as diffuse intrinsic pontine glioma [DIPG]) after systemic treatment with the drug.
Participants in this study will be given a one-time, intravenous (IV) dose of gemcitabine
prior to having standard-of-care surgery. During surgery, biopsies will be obtained for
clinical and research purposes along with a blood sample. Cerebrospinal Fluid (CSF) is
optional and will only be obtained if clinically indicated. This will be determined by the
investigators and the provider performing the procedure.
Because patients will be undergoing a biopsy/resection as part of their standard-of-care
therapy, this is an optimal time to obtain a tumor biopsy for this study. The biopsy will
serve to see if the study drug is penetrating the tumor. Patients will then enter a follow-up
period for 30 days post-surgery.
This trial is in conjunction with a University of Colorado trial started in 2016,
"Gemcitabine in Children With Newly-Diagnosed Diffuse Intrinsic Pontine Glioma"
(NCT02992015).
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