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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood, dialysate, intracavity fluid, and urine sample collection
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Dexamethasone — DRUG
  Given IV or PO
• Invasive Procedure — PROCEDURE
  Undergo placement of a temporary peritumoral microdialysis catheter
• Invasive Procedure — PROCEDURE
  Undergo intracavity drain placement
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• RAGE Antagonist FPS-ZM1 — DRUG
  Given PO
• Resection — PROCEDURE
  Undergo resection surgery

Study Details

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.

Key Dates

First listed

Aug 27, 2026

Start date

Feb 17, 2027

Status verified

Aug 2026

Primary completion

Aug 28, 2028

Completion

Aug 28, 2028

Study Design

Enrollment

24 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (FPS-ZM1 and dexamethasone)
  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.
• Experimental: Arm II (FPS-ZM1)
  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.

Primary Outcome Measure

RAGE Antagonist FPS-ZM1 (FPS-ZM1) related adverse events [ Time Frame: Up to 30 days post surgery ]

Locations (1)

Find similar trials in Duarte, CA

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