RecruitingPhase 2NCT06649851

G-CSF After Chemo-radiation in Patients With Glioblastoma

A Phase 2 Randomized Open-Label Pilot Study of Granulocyte Colony Stimulating Factor (G-CSF) to Preserve Brain Structure and Function Following Standard Chemoradiation in Patients With Newly Diagnosed MGMT-Methylated Glioblastoma

Sponsor

Massachusetts General Hospital

Enrollment

60 participants

Start Date

Apr 2, 2025

Study Type

INTERVENTIONAL

Conditions

Glioblastoma (GBM)MGMT-Methylated Glioblastoma Newly Diagnosed Glioblastoma Multiforme

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injections of G-CSF (a drug that stimulates white blood cell production) after the standard radiation plus chemotherapy treatment for glioblastoma (an aggressive brain tumor) can improve outcomes. Researchers think it may help stimulate the immune system to fight the tumor. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with glioblastoma (WHO grade 4, IDH wildtype) - Your tumor has a MGMT promoter methylation (a genetic marker that predicts better response to temozolomide) - You are scheduled for the standard 6-week radiation with temozolomide chemotherapy **You may NOT be eligible if...** - Your tumor does not have MGMT methylation - You are not eligible for standard radiation and temozolomide treatment - You have conditions that prevent safe treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGranulocyte Colony Stimulating Factor (G-CSF)

Subcutaneously injected study drug; standard target dose of 5-7 µg/kg/d.

RADIATIONRadiation Therapy + Temozolomide

Standard of care chemoradiation is radiation therapy + Temozolomide (TMZ). Chemoradiation (chemo-RT) includes an initial 6-week cycle, followed by a 4-week break, and up to 6 additional cycles of TMZ.