FPS-ZM1 With or Without Dexamethasone for Controlling Post Operative Cerebral Edema in Patients With Glioblastoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
The patient is taking a medication that is a strong or moderate inducer or inhibitor of major CYP450 isoenzymes and drug transporters, and the patient is not able to stop that medication at least 14 days prior to start of study treatment
The patient has a risk factor for torsades de pointes, such as structural heart disease (history of myocardial infarction, congestive heart failure, left ventricular hypertrophy), electrolyte abnormalities (hypokalemia, hypomagnesemia), bradycardia or heart blocks, or a family history of Long QT syndrome
The patient is taking a medication that prolongs the QT/QTc interval and is not able to stop that medication at least 14 days prior to start of study treatment
The patient is unwilling to stop taking herbal medications prior to the start of study treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood, dialysate, intracavity fluid, and urine sample collection
Computed Tomography
Procedure/SurgeryUndergo CT scan
Dexamethasone
DrugGiven IV or PO
Invasive Procedure
Procedure/SurgeryUndergo placement of a temporary peritumoral microdialysis catheter
Invasive Procedure
Procedure/SurgeryUndergo intracavity drain placement
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
RAGE Antagonist FPS-ZM1
DrugGiven PO
Resection
Procedure/SurgeryUndergo resection surgery
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Arm I (FPS-ZM1 and dexamethasone)Experimental treatment 7 interventions
Group B: Arm II (FPS-ZM1)Experimental treatment 7 interventions
Trial outcomes
Primary outcomes
1
RAGE Antagonist FPS-ZM1 (FPS-ZM1) related adverse events
Assessed per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Time frame
Up to 30 days post surgery2
Dose limiting toxicity rate
Assessed per CTCAE version 6.0.
Time frame
Up to 30 days post surgerySecondary outcomes
1
Doses of dexamethasone taken post-operatively by study participants on dose Level 4
Time frame
Up to 30 days post surgery2
FPS-ZM1 concentrations in enhancing tumor tissue
Time frame
Up to 30 days post surgery3
FPS-ZM1 concentrations in non-enhancing tumor tissue
Time frame
Up to 30 days post surgery4
FPS-ZM1 concentrations in cerebrospinal fluid (CSF)
Time frame
Up to 30 days post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: