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NMDA receptor antagonist

Memantine for Brain Tumor

Phase 3
Recruiting
Led By Nadia N Laack
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must weigh 15 kg or greater at time of study entry
Planned focal, cranial or craniospinal radiation treatment for a primary central nervous system tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up-to 36 months post baseline
Awards & highlights

Study Summary

This trial compares memantine to usual treatment in treating patients with brain tumors. Memantine may improve cognitive function in children and adolescents receiving brain radiation therapy to treat a primary brain tumor.

Who is the study for?
This trial is for children and adolescents aged 4-17 with newly diagnosed or recurrent primary brain tumors who haven't had prior cranial radiotherapy. Participants must weigh at least 15 kg, have adequate organ function, be able to undergo MRI scans, and understand English, French or Spanish. They can't join if they have a life expectancy under 18 months, allergies to memantine, uncontrollable seizures despite medication, severe diseases that could affect the study's outcome or are pregnant.Check my eligibility
What is being tested?
The trial is testing whether Memantine Hydrochloride can protect cognitive functions like attention and memory in kids receiving radiation therapy for brain tumors compared to usual treatment without Memantine. Cognitive assessments will measure the outcomes.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of Memantine may include dizziness, headache, confusion and constipation. Since it acts on nerve cells in the brain it might also cause mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh more than 15 kg.
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I am scheduled for targeted radiation therapy on my brain or spinal cord tumor.
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My brain tumor has not been treated with radiation before.
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My kidney function is normal or near normal.
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I am between 4 and 17 years old.
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My bilirubin levels are within the normal range for my age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up-to 36 months post baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and up-to 36 months post baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The mean slope of the Cogstate composite Z score (an average of detection, Identification, and one-back Z scores, each Z score calculated using Cogstate age-based normative data)
Other outcome measures
Composite cognitive score decline (0.5 standard deviation or more decline in Cogstate composite score relative to baseline)
Disease-free survival
Executive functioning score (assessed by the Cognitive Regulation Index of the Brief Rating Inventory of Executive Function)
+10 more

Side effects data

From 2011 Phase 2 trial • 29 Patients • NCT00585169
10%
Headache
7%
Light-headed/dizzy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Memantine 10mg
Memantine 30mg
Memantine 20mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (memantine hydrochloride)Experimental Treatment5 Interventions
Patients receive memantine hydrochloride orally PO QD for week 1 and then BID for weeks 2-24 in the absence of disease progression or unacceptable toxicity. Patients also complete cognitive testing over 20-30 minutes at baseline, end of radiation therapy, and at 3, 6, 12, 24, and 48 months. Patients undergo MRI and may optionally undergo blood sample collection throughout the trial.
Group II: Arm II (placebo)Placebo Group5 Interventions
Patients receive placebo PO QD for week 1 and then BID for weeks 2-24 in the absence of disease progression or unacceptable toxicity. Patients also complete cognitive testing over 20-30 minutes at baseline, end of radiation therapy, and at 3, 6, 12, 24, and 48 months. Patients undergo MRI and may optionally undergo blood sample collection throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1720
Memantine Hydrochloride
2018
Completed Phase 2
~170
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Cognitive Assessment
2011
Completed Phase 2
~1420

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for brain cancer include radiation therapy, chemotherapy, and targeted therapies. Memantine, an NMDA receptor antagonist, is being studied for its potential to protect cognitive function during radiation therapy by blocking receptors that contribute to cognitive decline. Chemotherapy agents like temozolomide work by damaging the DNA of cancer cells, leading to cell death. Targeted therapies aim to interfere with specific molecular pathways critical for tumor growth and survival. These mechanisms are important for brain cancer patients as they help in choosing treatments that effectively target the tumor while preserving cognitive and neurological function.
Imposing Phase II and Phase III Clinical Trials of Targeted Drugs for Glioblastoma: Current Status and Progress.Coagulation proteases and neurotransmitters in pathogenicity of glioblastoma multiforme.Phytochemical-Mediated Glioma Targeted Treatment: Drug Resistance and Novel Delivery Systems.

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
456 Previous Clinical Trials
239,595 Total Patients Enrolled
Nadia N LaackPrincipal InvestigatorChildren's Oncology Group
2 Previous Clinical Trials
39 Total Patients Enrolled

Media Library

Memantine Hydrochloride (NMDA receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04939597 — Phase 3
Brain Cancer Research Study Groups: Arm I (memantine hydrochloride), Arm II (placebo)
Brain Cancer Clinical Trial 2023: Memantine Hydrochloride Highlights & Side Effects. Trial Name: NCT04939597 — Phase 3
Memantine Hydrochloride (NMDA receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04939597 — Phase 3
~117 spots leftby Sep 2027