Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma
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|ClinicalTrials.gov Identifier: NCT04051047|
Recruitment Status : Not yet recruiting
First Posted : August 9, 2019
Last Update Posted : August 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glial Tumor of Brain Diffuse Intrinsic Pontine Glioma Glioma||Drug: Gemcitabine Procedure: Tumor biopsy and blood draw||Early Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||An Early Phase 1 Trial of Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma|
|Estimated Study Start Date :||November 30, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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.
Participants receive a one time IV dose of gemcitabine prior to having standard of care surgery.
Other Name: Gemzar
Procedure: Tumor biopsy and blood draw
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 [ Time Frame: Day 1 ]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.
- Concentration of gemcitabine in patient tumor sample [ Time Frame: Day 1 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051047
|United States, Michigan|
|The University of Michigan Rogel Cancer Center||Not yet recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Alyssa Paul firstname.lastname@example.org|
|Principal Investigator: Carl Koschmann|
|Principal Investigator:||Carl Koschmann, M.D.||University of Michigan|