Status:
WITHDRAWN
Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
Glial Tumor of Brain
Diffuse Intrinsic Pontine Glioma
Eligibility:
All Genders
3-17 years
Phase:
EARLY_PHASE1
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04051047
Start Date
November 30 2019
End Date
December 1 2021
Last Update
November 27 2019
Active Locations (1)
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1
The University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109