CompletedPhase 2

Memantine for Prevention of Cognitive Late Effects in Pediatric Patients Receiving Cranial Radiation Therapy for Localized Brain Tumors

United States41 participantsStarted 2017-11-07

Plain-language summary

Children with brain tumors who have had radiation therapy are at risk for problems with attention, memory, and problem solving. Such problems may cause difficulty in school and daily life. Memantine, the drug being used for this study, is not yet approved for use in children by the U.S. Food and Drug Administration. However, studies have shown some improvements in memory for patients with dementia, Attention Deficit Hyperactivity Disorder, and autism. Scientists have also used this medication for adult cancer patients receiving radiation therapy with results showing less cognitive declines over time compared to patients taking a placebo (inactive pill). These studies have also shown few side effects. This is a pilot/feasibility study and the first known study involving children with a cancer diagnosis or brain tumor. PRIMARY OBJECTIVES: * To estimate the participation rate in a study of memantine used as a neuro-protective agent in children undergoing radiotherapy for localized brain tumors (low grade glioma, craniopharyngioma, ependymoma, or germ cell tumor) * To estimate the rate of memantine medication adherence * To estimate the rate of completion of cognitive assessments SECONDARY OBJECTIVES: * To estimate the effect size of change in neurobehavioral outcomes (cognitive, social, quality of life, neurologic) associated with memantine * To evaluate the frequency and nature of memantine side effects as measured by the Systematic Assessment for Treatment Emergent Events (SAFTEE)

Who can participate

Age range

6 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 6 years to 21 years at time of study enrollment * Diagnosis of localized low grade glioma \[e.g., pilocytic astrocytoma, optic pathway glioma, ogligodendroglioma, ganglioglioma, pleomorphic xanthoastrocytoma (PXA)\], craniopharyngioma, ependymoma, or germ cell tumor * Initiating focal cranial radiation therapy (photon or proton) * Laboratory tests \[transaminases (ALT, AST, ALP), BUN and creatinine not greater than twice normal\] and normal ECG * Speak, read and understand English sufficiently to complete study assessments * Adequate vision and hearing for valid completion of study measures * Negative βHCG pregnancy test among females of childbearing age * Participant must be able to swallow pills (psychology staff will be available to assist with pill swallowing training if needed) * Parent/Legal guardian available and able to speak, read and understand English Exclusion Criteria: * Medical disorder that would endanger subject's well-being (e.g., uncorrected hypothyroidism, cardiac arrhythmia, hypertension requiring treatment, sick sinus syndrome, prolonged QTc) * History of significant neurological disease including poorly controlled seizures (i.e., \> 1 seizure per month; anti-epileptic medications are acceptable), stroke, or head injury with loss of consciousness * Psychiatric condition that would preclude or take precedence over study participation (e.g., active psychosis, suicidal ideation) * IQ below 70 based on baseline/screening assessmen…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent of Approached Participants Who Consent to Study Participation

Timeframe: Once, prior to enrollment

Percent of Participants Who Complete All 12 Weeks of Memantine/Placebo Therapy

Timeframe: At completion of memantine/placebo therapy (12 weeks)

Percent of Participants Who Complete at Least 3 of 4 Cognitive Assessments

Timeframe: At end of study (up to one year after study enrollment)

Trial details

NCT IDNCT03194906

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-28

Results submitted2024-05-07

View on ClinicalTrials.gov More Glioma of Brain trials