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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 belowSelect...
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.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up-to 36 months post baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up-to 36 months post baseline
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 moreSide effects data
From 2011 Phase 2 trial • 29 Patients • NCT0058516910%
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
~1730
Memantine Hydrochloride
2018
Completed Phase 2
~170
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Cognitive Assessment
2011
Completed Phase 2
~1320
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
454 Previous Clinical Trials
237,748 Total Patients Enrolled
Nadia N LaackPrincipal InvestigatorChildren's Oncology Group
2 Previous Clinical Trials
39 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a neurodevelopmental disorder like Down syndrome or Fragile X.I am not pregnant, as the study drug may harm the fetus.I weigh more than 15 kg.I am scheduled for targeted radiation therapy on my brain or spinal cord tumor.My brain tumor has not been treated with radiation before.I agree to use effective birth control during the study.I still have seizures despite taking my seizure medication correctly.My kidney function is normal or near normal.I am not allergic to memantine or placebos.I am between 4 and 17 years old.I have a condition or take medication that makes my urine more alkaline.I have never had radiation therapy to my head or spine.My bilirubin levels are within the normal range for my age.I can understand and speak English, French, or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (memantine hydrochloride)
- Group 2: Arm II (placebo)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial only meant for people under the age of 25?
"As this trial's eligibility requirements state, children as young as 4 years old may participate, with the upper age limit set at 17 years old."
Answered by AI
What is the Memantine Hydrochloride research landscape?
"The drug Memantine Hydrochloride was first studied in 1997 by Vanderbilt University Autonomic Dysfunction Center. Since then, there have been 136 completed studies and 27 studies that are ongoing. There is a large concentration of these active trials taking place in Miami, Florida."
Answered by AI
How many individuals are allowed to join this clinical trial?
"One hundred and sixty-two patients who meet the eligibility requirements must enroll in this clinical trial at sites such as Miami Cancer Institute in Miami, Florida and ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital in Toledo, Ohio."
Answered by AI
How many medical clinics are currently participating in this study?
"There are 54 sites where this clinical trial is taking place. Some notable locations include Miami Cancer Institute in Miami, ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital in Toledo, and Saint Christopher's Hospital for Children in Philadelphia."
Answered by AI
Who meets the necessary requirements to be a participant in this experiment?
"This clinical trial is enrolling 162 pediatric patients who have brain neoplasms. The eligible age range for participants is 4-17 years old. To qualify, patients must also weigh at least 15 kg, have not received cranial radiotherapy, and be newly diagnosed or have a recurrent primary brain tumor."
Answered by AI
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