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 study identifier
interventional
60
1 country
1
Study Start
April 2, 2025
Actual (reported)Primary Completion
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 17, 2024
Actual (reported)October 21, 2024
Actual (reported)April 2, 2025
Actual (reported)January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Incidence of adverse events (AEs)
Adverse events (AEs) will be assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. AEs will be listed and tabulated by type and study arm. AEs will also be categorized as study-related or not. The rate of AEs in all participants, both within study arms and overall, will be calculated and reported with exact 95% confidence intervals. All subjects who have completed at least 3 weeks of cranial radiation therapy will be include in the safety analyses.
From Day 0 (start of chemoradiotherapy (chemo-RT)) to end of treatment (EoT) +30 days, up to 35 weeks total.
Change in Brain Volume from Baseline
The degree of ventricular volume expansion (measured in % change from baseline) will be assessed by Magnetic Resonance Imaging (MRI), and serving as a surrogate marker for global brain volume loss and compared to a randomized control group. The contra-lesional lateral ventricle will be segmented in 3D Slicer or similar program to calculate the ventricular volume at each time point. Descriptive statistics with 95% CI will be provided for all endpoints and normality of data distribution will be assessed. If needed, Wilcoxon Rank-Sum test will be used to compare changes in ventricular volume expansion from baseline to endpoints between the groups and the Sign-rank tests will be used to evaluate within group changes between time points (two-sample or paired T-test will be used respectively if the data distribution warrants a parametric approach).
Per standard of care, participants undergo a 6-week chemoradiation (chemo-RT) cycle followed by a 4-week break. During this 4-week break after chemo-RT, participants receive granulocyte colony stimulating factor (G-CSF) once per day for 5 days (Days 7-11). After the 4-week break, as a part of standard care, participants may then receive up to 6 additional 4-week cycles of chemotherapy (temozolomide (TMZ)). During these additional TMZ cycles, participants will receive G-CSF once per day for 3 consecutive days (Days 14-16). G-CSF is injected under the skin (subcutaneously injected) by a study staff member, or self-administered (or a caregiver) can be trained by a study staff member to administer it at home. The chemo-RT (radiation therapy and chemotherapy (TMZ)) are standard of care in this study.
Participants receive standard of care chemoradiation (chemo-RT) which includes an initial 6-week chemo-RT cycle followed by a 4-week break, and up to 6 additional 4-week chemotherapy (temozolomide (TMZ)) cycles.
Subcutaneously injected study drug; standard target dose of 5-7 µg/kg/d.
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment and procedure
Radiation Therapy + Temozolomide
The registry names a treatment alongside a procedure. This entry does not establish their timing or actual administration.
View registry recordMassachusetts General Hospital
Boston, Massachusetts, 02114, United States
Jorg Dietrich, MD, PhD
Massachusetts General Hospital
First Submitted
October 17, 2024
First Posted
October 21, 2024
Study Start
April 2, 2025
Actual (reported)Primary Completion
January 31, 2027
EstimatedScreening (completed in Day -28 through Day 0) through up to 7 months after end of treatment (up to 62 weeks total).
Change in Neurocognitive Function (NCF)
Screening (completed in Day -28 through Day 0) through up to 7 months after end of treatment (up to 62 weeks total).
Change in Quality of Life (QOL)
Screening (completed in Day -28 through Day 0) through up to 7 months after end of treatment (up to 62 weeks total).
Change in Mood using Hospital Anxiety and Depression Scale (HADS)
Screening (completed in Day -28 through Day 0) through up to 7 months after end of treatment (up to 62 weeks total).
Overall Survival (OS)
Screening (completed in Day -28 through Day 0) through 24 months after enrollment.
Progression-Free Survival (PFS)
Screening (completed in Day -28 through Day 0) through 24 months after enrollment.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 5, 2026
Record last verified: 2026-04
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[jdietrich1@partners.org\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Source: ClinicalTrials.gov.
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