FPS-ZM1 With or Without Dexamethasone for Controlling Post Operative Cerebral Edema in Patients With Glioblastoma

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.

Conditions

• Glioblastoma
• Malignant Glioma
• Recurrent Glioblastoma
• Recurrent Malignant Glioma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood, dialysate, intracavity fluid, and urine sample collection

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Dexamethasone

Given IV or PO

PROCEDURE

Invasive Procedure

Undergo placement of a temporary peritumoral microdialysis catheter

PROCEDURE

Invasive Procedure

Undergo intracavity drain placement

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

RAGE Antagonist FPS-ZM1

Given PO

PROCEDURE

Resection

Undergo resection surgery

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Jana L Portnow · City of Hope Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-02-17

Primary Completion

2028-08-28

Completion

2028-08-28

FDA Drug

Yes

Countries

• United States

Study Locations