G-CSF for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether the drug G-CSF (granulocyte-colony stimulating factor) can improve brain health and cognitive function in individuals with glioblastoma multiforme (GBM). Participants will receive standard treatments like chemotherapy and radiation, with some also receiving G-CSF to assess any additional benefits. The trial seeks individuals newly diagnosed with MGMT-methylated GBM who can undergo standard radiation and chemotherapy. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on high doses of corticosteroids, you may need to taper down to a lower dose before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that G-CSF, also known as Filgrastim, is generally safe and well-tolerated by patients. Research suggests that using G-CSF after chemotherapy and radiation may help protect brain function without causing significant harm. In earlier studies, most patients experienced only mild side effects, such as bone pain or slight reactions at the injection site. G-CSF is also used in other treatments, which supports its safety.
Temozolomide (TMZ), the chemotherapy drug used with G-CSF, is a standard treatment for glioblastoma and is known to be safe. Common side effects of TMZ include nausea and tiredness, but these are usually manageable.
Overall, both G-CSF and TMZ have demonstrated safety in similar treatments, with side effects that are generally mild and manageable.12345Why are researchers excited about this study treatment for glioblastoma?
Researchers are excited about using G-CSF for glioblastoma because it introduces a novel way to potentially enhance recovery and counteract the side effects of standard treatments. Unlike traditional chemoradiation therapies, G-CSF stimulates the production of white blood cells, which helps bolster the immune system during the challenging treatment cycles. This boost could mean improved resilience to infections and better overall tolerance to chemotherapy. G-CSF is also easy to administer, as it can be injected under the skin by the patient or a caregiver, adding convenience and flexibility to the treatment regimen.
What evidence suggests that G-CSF might be an effective treatment for glioblastoma?
This trial will compare standard chemoradiation with and without the addition of G-CSF for patients with glioblastoma. Studies have shown that adding G-CSF to standard treatment can benefit patients with glioblastoma, a type of brain cancer. Research suggests that combining G-CSF with chemotherapy is safe and effective. Specifically, one study found that this combination helped patients live longer without their cancer worsening. G-CSF increases the production of white blood cells, supporting the body during cancer treatment. This may also help preserve brain health and maintain cognitive function. Early results are promising, but further research is needed to confirm these benefits.14678
Who Is on the Research Team?
Jorg Dietrich
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemoradiation
Participants undergo a 6-week chemoradiation (chemo-RT) cycle followed by a 4-week break
G-CSF Treatment
Participants receive G-CSF during the 4-week break and during up to 6 additional 4-week cycles of chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- G-CSF
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Published Research Related to This Trial
Citations
G-CSF After Chemo-radiation in Patients With Glioblastoma
This is an open-label, randomized, phase II clinical study of using G-CSF in patients with newly diagnosed, MGMT-methylated, GBM treated with standard of care ...
Granulocyte-macrophage colony-stimulating factor for ...
The combination of hypofractionated IMRT, TMZ and GM-CSF was efficacious and safe in patients with newly diagnosed GBM. Consent for publication. All patients ...
G-CSF After Chemo-radiation in Patients with Glioblastoma
Treatment with G-CSF will be initiated after chemo-RT and be completed after 6 cycles of adjuvant chemotherapy with Temozolomide. This study involves screening ...
Antiangiogenic Therapy for Glioblastoma: Current Status and ...
Outcome was notably improved for the combination arm including PFS-6 of 41%, compared to 11% and 18% for lomustine and bevacizumab alone, respectively. The ...
Glioblastoma-synthesized G-CSF and GM-CSF contribute ...
Data reviewed establish that any damage to brain tissue tends to cause an increase in G-CSF and/or GM-CSF (G(M)-CSF) synthesized by the brain.
G-CSF After Chemo-radiation in Patients With Glioblastoma
The study aims to evaluate G-CSF's effects on brain health and cognitive function. ... data exists ... safety and tolerability of G-CSF. Participants ...
G-CSF Following Standard Chemoradiation in Patients ...
Giving G-CSF after treatment with chemotherapy radiation therapy and temozolomide may be safe, tolerable and/or effective at preserving cognitive brain function ...
Chemoradiation and granulocyte-colony or ...
Use of G-CSF during concurrent chemotherapy and thoracic radiotherapy in patients with limited-stage small-cell lung cancer safety data from a phase II trial.
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