Clinical trial · Interventional
Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma
An Early Phase 1 Trial of Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma
NCT04051047CI-TRIAL-00041974withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn by Principal Investigator
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Intrinsic Pontine Glioma | Diffuse Intrinsic Pontine Glioma | ONTOLOGY_EXACT | 0.98 |
| Glial Tumor of Brain | — | UNRESOLVED | — |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Tumor biopsy and blood draw | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine
- description
- 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.
- interventionNames
- Drug: Gemcitabine
- Procedure: Tumor biopsy and blood draw
Primary outcomes (1)
- measure
- Number of participants with detectable intratumoral gemcitabine after systemic treatment with the drug
- timeFrame
- Day 1
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.