What side effects are associated with this type of intervention?

Common treatments for brain cancer, such as radiation therapy, chemotherapy, and surgery, have various side effects. Radiation therapy can cause fatigue, hair loss, skin changes, and cognitive decline. Chemotherapy may lead to nausea, vomiting, fatigue, and increased infection risk. Surgical interventions can result in complications like infection, bleeding, and neurological deficits. Memantine, an NMDA receptor antagonist, is being studied for its potential to protect cognitive function during radiation therapy.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for NMDA receptor antagonists like memantine for the treatment of brain cancer. However, memantine is being studied for its potential to protect cognitive function during radiation therapy for primary central nervous system tumors. Broadly, treatments for brain cancer often include radiation therapy, chemotherapy agents like temozolomide, and investigational therapies such as ONC201 and DNX-2401. These treatments aim to manage tumor growth and improve patient outcomes.

What other types of research exist?

Promising novel alternatives to Memantine for brain cancer patients include: 1) Tumor-Treating Fields (TTFields) combined with Temozolomide, which has shown improved survival rates and cognitive function in glioblastoma patients. 2) Bevacizumab, an anti-angiogenic therapy, which has been used in recurrent gliomas and may offer benefits in managing tumor growth and associated symptoms. 3) Proton therapy, which has demonstrated neurocognitive benefits in low-grade glioma patients. These alternatives are based on recent clinical trials and advancements in brain cancer treatment.

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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 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

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

Light-headed/dizzy

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met

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.