FPS-ZM1 + Dexamethasone for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I trial tests the safety, side effects, best dose and how well FPS-ZM1 works for controlling post operative cerebral edema in patients with glioblastoma. FPS-ZM1 works by blocking the pathway that controls inflammation. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving FPS-ZM1 with or without dexamethasone may be safe and/or effective in controlling post operative cerebral edema in patients with glioblastoma.
Who Is on the Research Team?
Jana L Portnow
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for people with glioblastoma or similar brain tumors who are having surgery to remove the tumor. Participants must be able to safely undergo surgery and follow-up procedures, and should not have conditions that would make participation unsafe.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- FPS-ZM1
Trial Overview
The study is testing a new drug called FPS-ZM1, which blocks inflammation pathways, either alone or together with dexamethasone (a steroid), to see if they can better control brain swelling after tumor surgery. The main focus is on safety and finding the best dose.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Starting 2 days prior to surgery, patients receive FPS-ZM1 PO QD and, if needed for physiologic replacement, a smaller dose of dexamethasone IV or PO QD until post operative day 11, in the absence of disease progression or unacceptable toxicity. On day of surgery patients undergo standard of care resection and, if possible, undergo placement of a temporary peritumoral microdialysis catheter and intracavity drain for collection of dialysate and intracavity fluid. Patients undergo urine sample collection during screening, lumbar puncture with cerebrospinal fluid collection and CT scan on study and brain MRI, and blood sample collection throughout the study.
Starting 2 days prior to surgery, patients receive FPS-ZM1 PO QD until post operative day 11, and dexamethasone IV or PO QD taper until post operative day 14, in the absence of disease progression or unacceptable toxicity. On day of surgery patients undergo standard of care resection and, if possible, undergo placement of a temporary peritumoral microdialysis catheter and intracavity drain for collection of dialysate and intracavity fluid. Patients undergo urine sample collection during screening, lumbar puncture with cerebrospinal fluid collection and CT scan on study and brain MRI, and blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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