This early phase I trial studies how well gemcitabine hydrochloride works in treating patients with diffuse midline glioma. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Additional locations may be listed on ClinicalTrials.gov for NCT02992015.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To measure the concentration of gemcitabine hydrochloride (gemcitabine) and its metabolites in patient biopsy-derived diffuse midline glioma tissue after pre-biopsy treatment and to compare these concentrations to historical control levels achieved in adult glioblastoma (GBM) tissue and to know in vitro inhibitory drug concentrations for diffuse midline gliomas, cell lines (previously classified as diffuse intrinsic pontine glioma (DIPG).
OUTLINE:
Within 4 hours of standard of care surgery, patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes.
After completion of study treatment, patients are followed up for 30 days.
Lead OrganizationChildren's Hospital Colorado
Principal InvestigatorAdam L. Green