Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma

• Status: Withdrawn
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Rogel Cancer Center
• Collaborator: University of Colorado, Denver
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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