Recruiting

Phase 2

G-CSF & TMZG-CSF After Chemo-radiation in Patients With Glioblastoma

Sponsor:

Massachusetts General Hospital

Code:

NCT06649851

Conditions

MGMT-Methylated Glioblastoma

Glioblastoma (GBM)

Newly Diagnosed Glioblastoma Multiforme

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Granulocyte Colony Stimulating Factor (G-CSF)

Radiation Therapy + Temozolomide

Study Details

Brief 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

Conditions

MGMT-Methylated Glioblastoma

Glioblastoma (GBM)

Newly Diagnosed Glioblastoma Multiforme

Study ID

NCT06649851

Start date

Apr 2, 2025

Status verified date

Apr, 2026

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 patients with Gilbert's syndrome, total bilirubin can be ≤ 3xULN.

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 Criteria:

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Standard Chemoradiation combined with G-CSF

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.

other: Standard Chemoradiation

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.

Interventions

Granulocyte Colony Stimulating Factor (G-CSF)

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

Radiation 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.

Primary outcome measure

Incidence of adverse events (AEs) [ Time Frame: 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 [ Time Frame: Screening (completed in Day -28 through Day 0) through up to 7 months after end of treatment (up to 62 weeks total). ]

Central Contacts and Locations

Central contacts

Jorg Dietrich, MD, PhD

617-724-8770 jdietrich1@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jorg Dietrich, MD, PhD

617-724-8770 jdietrich1@partners.org

Principal Investigator:

Jorg Dietrich, MD, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

MGMT-methylated glioblastoma multiforme (GBM)
Newly diagnosed MGMT-methylated glioblastoma multiforme (GBM)
Glioblastoma
Glioblastoma Multiforme (GBM)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-05.