Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma

Withdrawn before enrolling · Early Phase 1

Conditions studied: Glial Tumor of Brain, Diffuse Intrinsic Pontine Glioma, Glioma

In brief

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.

Key facts

Study ID

NCT04051047

Run by

University of Michigan Rogel Cancer Center

People needed

0

Starts

2019-11-30

Expected to finish

2021-12-01

Last updated by the study team

2019-11-27

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than or equal to 3 years and less than 18 years at the time of enrollment.
• Patients must meet both of the first two conditions, OR the third:
• Clinical findings consistent with a presumed new diagnosis of diffuse midline glioma (DMG) in the opinion of the treating neuro-oncologist, AND
• Brain MRI findings consistent with a new diagnosis of DMG based on multidisciplinary consensus after review of imaging
• OR, recurrent DMG requiring tumor resection or biopsy
• Adequate bone marrow, liver, renal and metabolic function (per protocol)
• Adequate coagulation defined as Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ upper limit of normal (ULN ) for age
• Patients must meet one of the following performance scores:
• ECOG performance status scores of 0, 1, or 2; 8
• Karnofsky score of ≥ 60 for patients > 16 years of age; or
• Lansky score of ≥ 60 for patients ≤ 16 years of age
• DMG biopsy/resection is planned for the clinical care of the patient independent of study participation by the treating pediatric neurosurgeon and neuro-oncologist.
• Informed consent and assent obtained as appropriate.

You may not qualify if…

• Pregnant or breastfeeding patients are not eligible due to teratogenic effects seen in animal/human studies
• Patients who have received any tumor-directed therapy prior to biopsy are not eligible. Concurrent treatment with corticosteroids is allowed.
• Any tumor-specific or clinical features that make surgical intervention unsafe in the opinion of the treating neurosurgeon.
• Patients with personal or family history of bleeding disorders are not eligible.
• Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are not eligible.
• Patients with known hypersensitivity to gemcitabine

Where it is running

• The University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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