A Phase 1 Study of the RAGE Inhibitor FPS-ZM1 for Controlling Post-Operative Cerebral Edema in Glioblastoma Patients
City of Hope Medical Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. Determine the maximum feasible dose (MFD) of RAGE antagonist FPS-ZM1 (FPS-ZM1) administered peri-operatively to participants with newly diagnosed or recurrent glioblastoma. SECONDARY OBJECTIVES: I. Assess the ability of FPS-ZM1 to control participants' symptoms of post-operative cerebral edema when administered as monotherapy. II. Describe the systemic pharmacokinetics and central nervous system (CNS) penetration of FPS-ZM1 based on concentrations of FPS-ZM1 in peripheral blood, cerebrospinal fluid (CSF), brain tumor tissue and resection cavity fluid (when obtainable)…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent given by the participant. Non-English speaking adults are eligible for participation if they have the capacity to understand and consent to the study procedures * Age: ≥ 18 years * Karnofsky Performance Status (KPS) ≥ 70% * Histologically confirmed glioblastoma or radiographic findings consistent with a high grade glioma * Newly diagnosed or recurrent tumor * The patient is planning to undergo a standard-of-care craniotomy for gross total resection of enhancing tumor * The patient's pre-operative brain MRI shows the presence of mild to moderat…
Interventions
- ProcedureBiospecimen Collection
Undergo blood, dialysate, intracavity fluid, and urine sample collection
- ProcedureComputed Tomography
Undergo CT scan
- DrugDexamethasone
Given IV or PO
- ProcedureInvasive Procedure
Undergo placement of a temporary peritumoral microdialysis catheter
- ProcedureInvasive Procedure
Undergo intracavity drain placement
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- DrugRAGE Antagonist FPS-ZM1
Given PO
- ProcedureResection
Undergo resection surgery
Location
- City of Hope Medical CenterDuarte, California