Actively Recruiting
Phase 2 Randomized Study of Granulocyte Colony Stimulating Factor (G-CSF) to Protect Brain Health Following Standard Chemoradiation in Newly Diagnosed MGMT-Methylated Glioblastoma
Led by Massachusetts General Hospital · Updated on 2026-05-05
60
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of granulocyte colony stimulating factor (G-CSF) in patients with newly diagnosed MGMT-methylated glioblastoma multiforme (GBM) who are receiving standard chemoradiation treatment. This phase II clinical study aims to assess how G-CSF affects brain structure, cognitive function, and overall brain health, as well as its safety and tolerability when combined with radiation and chemotherapy. The study drugs involved include G-CSF (Filgrastim) and temozolomide, a chemotherapy drug approved for GBM treatment. Participants will be randomly assigned to receive either standard chemoradiation alone or standard chemoradiation combined with G-CSF. The treatment begins with a 6-week cycle of radiation therapy combined with temozolomide, followed by a 4-week break during which G-CSF is given daily for 5 days. After the break, participants may receive up to 6 additional 4-week chemotherapy cycles with temozolomide, during which G-CSF is administered daily for 3 days each cycle. G-CSF is injected under the skin and can be given by study staff or self-administered after training. Participants will be involved in the study for up to 24 months, including screening, treatment, and follow-up visits. Brain MRI scans with contrast, neurocognitive tests, quality of life and mood assessments, and safety monitoring will be performed throughout. Researchers will measure adverse events, changes in brain volume, cognitive function, mood, survival, and progression-free survival. Follow-up continues for up to 12 months after treatment to monitor long-term outcomes.
CONDITIONS
Brief 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
- Positive MGMT promoter methylation status by standard testing
- Planned 6-week standard radiation therapy with concurrent and adjuvant temozolomide chemotherapy
- Age 18 years or older
- Karnofsky Performance Status greater than 60
- No prior cranial irradiation
- No 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 as defined by specific blood and liver/kidney tests
- Undetectable HBV viral load if history of chronic hepatitis B
- Prior or concurrent malignancy allowed if it does not interfere with study
- Ability and willingness to provide informed consent
You will not qualify if you...
- Receiving other investigational agents
- Allergic reactions to G-CSF or similar compounds
- Uncontrolled illness affecting leukocyte counts, including severe infections or HIV
- Pregnant or breastfeeding women
- 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
- Medical conditions with elevated risk of G-CSF toxicity such as sickle cell disease, congenital neutropenia, or hematological malignancy
- Dependence on high doses of corticosteroids (dexamethasone 8mg daily or more) or inability to taper to 4mg or less before treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive 6 weeks of standard chemoradiation therapy, which includes radiation therapy combined with temozolomide chemotherapy.
Weekly visits for 6 weeks
Duration - Up to 7 months
Participants in the experimental arm receive granulocyte colony stimulating factor (G-CSF) injections during a 4-week break after chemoradiation and during up to 6 additional 4-week cycles of chemotherapy with temozolomide. Participants in the control arm receive standard chemotherapy without G-CSF.
Daily G-CSF injections for 5 days during the 4-week break, and daily injections for 3 consecutive days during each chemotherapy cycle
Duration - Up to 19 months
Participants are monitored for safety, brain health, cognitive function, and survival outcomes after treatment ends.
Regular follow-up visits over up to 19 months
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
J
Jorg Dietrich, MD, PhD
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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