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G-CSF After Chemoradiation for Glioblastoma

This study is looking at whether a drug called Granulocyte Colony Stimulating Factor (G-CSF, also known as Filgrastim) can help protect the brain during standard treatment for newly diagnosed glioblastoma multiforme (GBM). GBM is a type of brain cancer. You would receive standard treatment, which includes radiation therapy and chemotherapy with Temozolomide (TMZ). The study will compare patients who receive G-CSF along with standard treatment to those who receive standard treatment alone. Researchers want to see if G-CSF can reduce negative side effects on brain health, including brain structure and thinking abilities. To join, you must have newly diagnosed GBM that has a specific genetic marker called MGMT promoter methylation. This study plans to enroll 60 participants. The current recruitment status is unclear.

Study design
This is an open-label, randomized Phase II study. Participants will be randomly assigned to one of two groups: standard treatment with G-CSF or standard treatment alone.
What's involved
You would undergo screening, standard radiation and chemotherapy, study treatment, study visits, and follow-up visits. Your total participation could last up to 24 months.
Compensation
Not stated in the trial record.
Follow-up
You will have active follow-up visits for up to 7 months after study treatment ends, followed by 12 months of survival follow-up.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06649851

G-CSF After Chemo-radiation in Patients With Glioblastoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Massachusetts General Hospital
~60 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Granulocyte Colony Stimulating Factor (G-CSF)Radiation Therapy + Temozolomide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over From Day 0 (start of chemoradiotherapy (chemo-RT)) to end of treatment (EoT) +30 days, up to 35 weeks total.
+1 more outcome measured

Conditions

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

Explore related trials

GlioblastomaIDH1 wt AlleleMGMT Gene

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Jorg Dietrich, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Jorg Dietrich, MD, PhD
[email protected]
617-724-8770
Email the study team

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Eligibility criteria

Inclusion

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., Alzheimer's Disease, Fronto-temporal Dementia (FTD), Parkinson's Disease, Motor Neuron Disease, etc.) prior to diagnosis of GBM.
Life expectancy of greater than 6 months.
Must be able to undergo repeated brain Magnetic resonance imaging (MRI) studies with administration of gadolinium (contrast enhanced brain MRI).
Participants must have adequate organ and bone marrow function (as defined below) to be able to receive standard chemoradiation therapy:
leukocytes ≥2,500/mcL
absolute neutrophil count≥1,500/mcL
platelets ≥100,000/mcL
total bilirubin≤ institutional upper limit of normal (ULN)
AST(SGOT)/ALT(SGPT)≤3 × institutional ULN creatinine≤ institutional ULN OR
glomerular filtration rate (GFR) ≥60 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2.
For participants with evidence of chronic hepatitis B virus (HBV) infection by history, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (use of granulocyte colony stimulating factor (G-CSF)) are eligible for this trial.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion

Participants who are receiving any other investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to G-CSF (Filgrastim associated allergic reactions).
Participants with uncontrolled intercurrent illness that could influence leukocyte counts, such as severe infection requiring intravenous antibiotics, or known HIV (human immunodeficiency virus), since HIV/AIDS is an immunocompromising disease affecting lymphocyte counts (one of the correlative biomarkers in this study)
Pregnant women are excluded from this study because of the use of cytotoxic chemotherapy (temozolomide) and radiation, given as part of standard of care in this trial, is of teratogenic potential or has abortifacient effects. Because there is a risk for adverse events in nursing infants secondary to treatment of the mother with cytotoxic chemotherapy, breastfeeding should be discontinued if the mother is treated with cytotoxic chemotherapy.
Participants must be able to undergo repeated neurocognitive testing in English (or Spanish). As cognitive outcome is one of the main secondary endpoints of this study, the lack of normative and comparison data for non-English or non-Spanish-speaking patients would confound this outcome in our small sample size (see Statistical Analysis Plan for more details). Presence of significant aphasia or any other language impairment at time of diagnosis with GBM is considered an exclusion criterion. Any concerns or questions about a subject's ability to participate in neurocognitive testing can be directed to the study investigators for further discussion and clarification.
Participants with active thromboembolic event (pulmonary embolism or deep venous thrombosis) or prior thromboembolic event within 6 months prior to diagnosis of GBM may need to be excluded because of possible risks of thromboembolism with the use of G-CSF and will require further discussion with the PI prior to enrollment on a case-by-case basis.
Participants with the following medical conditions are excluded and not eligible based on elevated risk of G-CSF associated toxicity: Sickle cell disease or sickle cell trait, congenital neutropenia, hematological malignancy (leukemia or myelodysplastic syndrome).
Patients who are dependent on high doses of corticosteroids equivalent to 8mg of daily dexamethasone or more, or who are expected to be unable to taper steroids post-operatively to a dose of 4mg of dexamethasone or less prior to start of chemo-RT.

What this trial measures

  • Incidence of adverse events (AEs)From Day 0 (start of chemoradiotherapy (chemo-RT)) to end of treatment (EoT) +30 days, up to 35 weeks total.

    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.

  • Change in Brain Volume from BaselineScreening (completed in Day -28 through Day 0) through up to 7 months after end of treatment (up to 62 weeks total).

    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).