Study on G-CSF After Chemo-radiation in Patients with Glioblastoma

Sponsor: Massachusetts General Hospital

Sponsor score: 0

ClinicalTrials ID:NCT06649851

Provider View

This clinical trial is exploring whether a drug called G-CSF can help protect brain health and improve cognitive function in patients with a specific type of brain cancer, glioblastoma, who are receiving standard chemotherapy and radiation treatment.

Patient Parameters

Program Overview

The study is investigating the effects of a drug called G-CSF (also known as Filgrastim) on patients with glioblastoma, a type of brain cancer. Researchers want to see if G-CSF can help maintain brain health and cognitive function during and after standard treatment with chemotherapy and radiation. The study involves two groups: one receiving the standard treatment with G-CSF and the other without G-CSF. Participants will be monitored for up to 24 months, including treatment and follow-up visits.

Description

This study is testing whether G-CSF can reduce the negative effects of radiation and chemotherapy on the brain in patients with newly diagnosed glioblastoma. Participants will be randomly assigned to receive either standard chemotherapy and radiation with G-CSF or without it. The treatment with G-CSF will start after the initial chemo-radiation and continue for up to 7 months, depending on the number of chemotherapy cycles. The study will last up to 24 months, including treatment and follow-up visits.

G-CSF is a protein that helps the body produce more blood cells and has properties that may protect brain cells. It is already approved for use in patients with low white blood cell counts due to chemotherapy. This study will test if G-CSF can also support brain health during cancer treatment. Up to 60 participants will be enrolled.

Participants will undergo standard radiation and chemotherapy, along with study visits and follow-up appointments. The study aims to determine if G-CSF can protect brain cells and improve recovery after treatment. The FDA has approved the use of temozolomide and radiation therapy for glioblastoma, but G-CSF's use for brain health is still being studied.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of glioblastoma, a type of brain cancer.
  • Cancer must have a specific genetic marker called MGMT promoter methylation.
  • Treatment plan includes 6 weeks of radiation and 6 months of chemotherapy with temozolomide.
  • Must be 18 years or older.
  • Must have a good performance status, meaning able to carry out daily activities.
  • No previous radiation to the brain.
  • No existing diagnosis of dementia or neurodegenerative diseases.
  • Life expectancy of more than 6 months.
  • Must be able to undergo MRI scans with contrast.
  • Must have adequate organ and bone marrow function as shown by specific blood tests.
  • For those with hepatitis B, the virus must be under control.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Currently receiving other experimental treatments.
  • Allergic to G-CSF or similar drugs.
  • Have uncontrolled illnesses that affect white blood cell counts, like severe infections or HIV.
  • Pregnant or breastfeeding women.
  • Must be able to complete cognitive tests in English or Spanish.
  • Have active blood clots or recent history of blood clots.
  • Have certain medical conditions like sickle cell disease or blood cancers.
  • Rely on high doses of steroids or unable to reduce steroid use before starting treatment.

Locations

FACILITYZIPCITYSTATE
Massachusetts General Hospital02114BostonMassachusetts

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