Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649851
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
G-CSF After Chemo-radiation in Patients with Glioblastoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Open-Label Pilot Study of Granulocyte Colony Stimulating Factor G-CSF to Preserve Brain Structure and Function Following Standard Chemoradiation in Patients with Newly Diagnosed MGMT-Methylated Glioblastoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-CSFs 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
The name of the study drugs involved in this study are
G-CSF also called Filgrastim
Temozolomide TMZ a standard of care chemotherapy drug
Detailed Description:
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 radiation with concurrent and adjuvant chemotherapy with temozolomide The investigators are testing whether G-CSF can reduce the negative side effects from radiation and chemotherapy on brain health The investigators are specifically testing the effects of G-CSF on brain structure cognitive function and general brain health and the safety and tolerability of G-CSF
Participants will be randomized in a 11 fashion to receive either standard of care chemoradiotherapy chemo-RT in combination with G-CSF or standard of care chemo-RT without G-CSF 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 for eligibility standard of care radiation therapy and chemotherapy study treatment and study visits and follow-up visits Participants will be in the study for up to 24 months including 6 weeks of standard of care chemo-RT up to 7 months of G-CSF treatment depending on the number of additional chemotherapy cycles given as a part of standard care and 12 months of active follow-up visits after study treatment ends Long-term follow-up review of medical chart will occur for up to 5 years after enrollment Up to 40 participants will be enrolled in this study
Granulocyte colony-stimulating factor G-CSF is a protein that stimulates bone marrow to produce stem cells and blood cells and release them into the bloodstream It is known to have anti-inflammatory and neuroprotective properties slowing or halting the loss of neurons G-CSF is also called Filgrastim and brand names include Granix Neupogen and Zarxio In addition to testing the safety and tolerability of G-CSF the researchers in this study are testing whether or not G-CSF can protect cells in the brain or enhance repair in the brain after chemoradiation and during chemotherapy The US Food and Drug Administration FDA has not approved G-CSF to support brain health and cognitive function However G-CSF has been approved for several decades and in patients with any type of cancer who develop neutropenia low white blood cell counts following chemotherapy including in patients with glioblastoma or in patients following stem cell transplantation with low white cell blood counts
The US Food and Drug Administration FDA has approved temozolomide as a treatment option for GBM Temozolomide is given as standard of care chemotherapy in this study
The radiation therapy used in this study is standard of care and approved by the US Food and Drug Administration FDA as a treatment option for GBM
Participants will be randomized in a 11 fashion to receive either standard of care chemoradiotherapy chemo-RT in combination with G-CSF or standard of care chemo-RT without G-CSF 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 for eligibility standard of care radiation therapy and chemotherapy study treatment and study visits and follow-up visits Participants will be in the study for up to 24 months including 6 weeks of standard of care chemo-RT up to 7 months of G-CSF treatment depending on the number of additional chemotherapy cycles given as a part of standard care and 12 months of active follow-up visits after study treatment ends Long-term follow-up review of medical chart will occur for up to 5 years after enrollment Up to 40 participants will be enrolled in this study
Granulocyte colony-stimulating factor G-CSF is a protein that stimulates bone marrow to produce stem cells and blood cells and release them into the bloodstream It is known to have anti-inflammatory and neuroprotective properties slowing or halting the loss of neurons G-CSF is also called Filgrastim and brand names include Granix Neupogen and Zarxio In addition to testing the safety and tolerability of G-CSF the researchers in this study are testing whether or not G-CSF can protect cells in the brain or enhance repair in the brain after chemoradiation and during chemotherapy The US Food and Drug Administration FDA has not approved G-CSF to support brain health and cognitive function However G-CSF has been approved for several decades and in patients with any type of cancer who develop neutropenia low white blood cell counts following chemotherapy including in patients with glioblastoma or in patients following stem cell transplantation with low white cell blood counts
The US Food and Drug Administration FDA has approved temozolomide as a treatment option for GBM Temozolomide is given as standard of care chemotherapy in this study
The radiation therapy used in this study is standard of care and approved by the US Food and Drug Administration FDA as a treatment option for GBM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None