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Recruiting Phase 2 NCT06649851

G-CSF After Chemo-radiation in Patients With Glioblastoma

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Trial Parameters

Condition MGMT-Methylated Glioblastoma
Sponsor Massachusetts General Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-04-02
Completion 2027-01-31
Interventions
Granulocyte Colony Stimulating Factor (G-CSF)Radiation Therapy + Temozolomide

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Brief Summary

This research study involves the study of granulocyte colony stimulating factor (G-CSF) in patients with MGMT-methylated glioblastoma multiforme (GBM) that are undergoing standard chemoradiation. The study aims to evaluate G-CSF's effects on brain health and cognitive function. The name of the study drugs involved in this study are: * G-CSF (also called Filgrastim) * Temozolomide (TMZ), a standard of care chemotherapy drug

Eligibility Criteria

Inclusion Criteria: * Participants must have confirmed newly diagnosed glioblastoma multiforme (GBM), World Health Organization (WHO) grade 4, IDH wildtype, either by histological or molecular criteria. * Molecular analysis needs to confirm a positive MGMT promoter methylation status using standard institutional testing methods. * Treatment needs to involve a planned 6-week course of standard of care radiation therapy with concurrent and adjuvant 6 monthly chemotherapy with temozolomide. Patients scheduled to receive an abbreviated radiation course (e.g., 3 weeks in elderly patients) are eligible. * Age ≥18 years. GBM is considered a biologically distinct disease in children. Children are excluded from this study but will be eligible for future pediatric clinical trials. * Karnofsky Performance Status (KPS) \> 60, see Appendix A * No prior cranial irradiation. * No existing diagnosis of clinical dementia or high clinical suspicion for presence of any neurodegenerative disease (e.g., Al

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