NCT04051047

Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma

An Early Phase 1 Trial of Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Glial Tumor of Brain
• Diffuse Intrinsic Pontine Glioma
• Glioma

Interventions

Type	Name	Description
DRUG	Gemcitabine	Participants receive a one time IV dose of gemcitabine prior to having standard of care surgery.
PROCEDURE	Tumor biopsy and blood draw	As part of standard of care, all participants will undergo tumor biopsy and collection of peripheral blood.

Timeline

• Start date: 2019-11-30
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2019-08-09
• Last updated: 2019-11-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study