Actively Recruiting
G-CSF After Chemo-radiation in Patients With Glioblastoma
Led by Massachusetts General Hospital · Updated on 2026-05-05
60
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
G-CSF After Chemo-radiation in Patients With Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed newly diagnosed glioblastoma multiforme (GBM), WHO grade 4, IDH wildtype by histological or molecular criteria
- Positive MGMT promoter methylation status confirmed by standard testing
- Planned treatment with 6-week standard radiation plus concurrent and 6 monthly cycles of adjuvant temozolomide chemotherapy (abbreviated radiation course allowed)
- Age 18 years or older
- Karnofsky Performance Status (KPS) greater than 60
- No prior cranial irradiation
- No diagnosis or suspicion of clinical dementia or neurodegenerative disease before GBM diagnosis
- Life expectancy greater than 6 months
- Ability to undergo repeated contrast-enhanced brain MRI
- Adequate organ and bone marrow function (leukocytes ≥2,500/mcL, absolute neutrophil count ≥1,500/mcL, platelets ≥100,000/mcL, total bilirubin ≤ institutional upper limit of normal, AST/ALT ≤3 times institutional upper limit of normal, creatinine ≤ institutional upper limit of normal or GFR ≥60 mL/min/1.73 m2 or ≥30 with supportive data)
- For patients with Gilbert's syndrome, total bilirubin ≤3 times upper limit of normal
- For chronic hepatitis B infection, viral load must be undetectable on suppressive therapy if indicated
- Prior or concurrent malignancies allowed if they do not interfere with safety or efficacy assessment
- Ability and willingness to provide informed consent
You will not qualify if you...
- Current use of other investigational agents
- History of allergic reactions to G-CSF or similar compounds
- Uncontrolled illnesses affecting leukocyte counts such as severe infection requiring IV antibiotics or known HIV
- Pregnancy or breastfeeding
- Inability to undergo neurocognitive testing in English or Spanish
- Significant aphasia or language impairment at GBM diagnosis
- Active or recent thromboembolic events (within 6 months) unless discussed with investigator
- Medical conditions increasing risk of G-CSF toxicity such as sickle cell disease, congenital neutropenia, or hematological malignancies
- Dependence on high-dose corticosteroids (≥8mg dexamethasone daily) or inability to taper to ≤4mg before chemoradiation start
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
J
Jorg Dietrich, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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