An Early Phase 1 interventional study of Gemcitabine and Tumor biopsy and blood draw in Glial Tumor of Brain, Diffuse Intrinsic Pontine Glioma and Glioma, sponsored by University of Michigan Rogel Cancer Center. Withdrawn at 1 site in United States. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by University of Michigan Rogel Cancer Center · Early Phase 1, Interventional, and Basic science
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).
122 studies on the registry are indexed under Diffuse Intrinsic Pontine Glioma; 40 are open to participants now.
Browse Diffuse Intrinsic Pontine Glioma studies →University of Michigan Rogel Cancer Center is the lead sponsor of 322 studies on the registry; 47 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 31 (67%) have results posted.
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Patients must meet both of the first two conditions, OR the third:
Patients must meet one of the following performance scores:
Exclusion Criteria:
Gemcitabine will be given at 2100 mg/m2 IV over 30 minutes within 4 hours of planned surgical procedure. The surgical procedure is standard of care.
Drug: Gemcitabine · Procedure: Tumor biopsy and blood draw
Participants receive a one time IV dose of gemcitabine prior to having standard of care surgery.
Also known as: Gemzar
As part of standard of care, all participants will undergo tumor biopsy and collection of peripheral blood.
Number of participants with detectable intratumoral gemcitabine after systemic treatment with the drug
Gemcitabine will be considered to be detectable in a participant's tumor sample if gemcitabine or one of its metabolites (difluorodeoxyuridine \[dFdU\] or gemcitabine triphosphate \[dFdCTP\]) is detected at a measurable level in any of the participant's tumor samples. Undetectable gemcitabine will be defined as gemcitabine, dFdU, and dFdCTP levels below the detectable limits for all of an individual participant's samples, in the setting of detectable gemcitabine, dFdU, or dFdCTP in the plasma and/or cerebrospinal fluid (CSF) for that patient, and the pathologic review showing viable tumor tissue.
Time frame: Day 1
Concentration of gemcitabine in patient tumor sample
Gemcitabine, dFdU and dFdCTP will be quantified in the available tumor sample(s), in plasma, and in CSF (if available). For this pilot trial, gemcitabine PK results will be analyzed descriptively, and this trial is not designed for statistical analysis.
Time frame: Day 1
Plan to share: No
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This study is withdrawn, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gemcitabine
Diffuse Intrinsic Pontine Glioma →
University of Michigan Rogel Cancer Center →