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G-CSF for Glioblastoma

Boston, MA

Phase 2

Waitlist Available

Led By Jorg Dietrich, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 not eligible

Molecular analysis needs to confirm a positive MGMT promoter methylation status using standard institutional testing methods

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening (completed in day -28 through day 0) through 12 (±2 weeks) months post-treatment, up to 92 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at how a drug called granulocyte colony stimulating factor (G-CSF) affects brain health and cognitive function in patients with a specific type of brain cancer called MGMT-methyl

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Who is the study for?

This trial is for adults over 18 with newly diagnosed glioblastoma multiforme (GBM), WHO grade 4, IDH wildtype. They must have a positive MGMT promoter methylation status, good performance status (KPS > 60), and life expectancy over 6 months. Patients need to be able to undergo standard chemoradiation therapy and brain MRIs. Exclusions include pregnancy, other investigational drugs use, severe infections or HIV/AIDS, prior cranial irradiation, certain allergies, non-English/Spanish speakers due to cognitive testing requirements.Check my eligibility

What is being tested?

The study tests the effects of granulocyte colony stimulating factor (G-CSF) on brain health and cognitive function in GBM patients undergoing standard chemoradiation therapy. G-CSF is given alongside Temozolomide chemotherapy during a planned course of radiation treatment.See study design

What are the potential side effects?

Potential side effects may include allergic reactions similar to those seen with compounds like G-CSF such as Filgrastim-associated allergies. There's also an elevated risk of thromboembolic events like pulmonary embolism or deep venous thrombosis associated with G-CSF.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am set to undergo a 6-week radiation therapy and 6 months of chemotherapy with temozolomide.

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My cancer has a specific genetic feature known as MGMT promoter methylation.

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My hepatitis B virus load is undetectable with treatment.

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I am 18 years old or older.

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I can care for myself but may need occasional help.

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I have never had radiation therapy to my head.

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I have not been diagnosed with dementia or any neurodegenerative disease before my brain cancer diagnosis.

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My diagnosis is grade 4 glioblastoma, IDH wildtype.

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I can have MRIs with contrast for my brain.

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My organs and bone marrow are healthy enough for standard cancer treatment.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, as the treatment in this study could harm a pregnancy.

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I do not have any severe infections or HIV that could affect my white blood cell count.

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I do not have sickle cell, congenital neutropenia, leukemia, or myelodysplastic syndrome.

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I rely on high doses of steroids or can't reduce my steroid use before starting treatment.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening (completed in day -28 through day 0) through 12 (±2 weeks) months post-treatment, up to 92 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening (completed in day -28 through day 0) through 12 (±2 weeks) months post-treatment, up to 92 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (completed in day -28 through day 0) through 12 (±2 weeks) months post-treatment, up to 92 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Brain Volume through 12 Months Follow-Up

Incidence of adverse events (AEs)

Secondary study objectives

Change in Mood from Baseline through 12-month Follow-Up

Change in Neurocognitive Function (NCF) From Baseline through 12 Month Follow-up

Change in Quality of Life (QOL) from Baseline through 12-month Follow-Up

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Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard Chemoradiation combined with G-CSFExperimental Treatment2 Interventions

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.

Group II: Standard ChemoradiationExperimental Treatment1 Intervention

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.

0 / 14Eligibility criteria met