Memantine for the Reduction of Cognitive Impairment After Radiation Therapy in Pediatric Patients With Central Nervous System Tumors

STATUS

Recruiting
participants needed

20
sponsor

Mayo Clinic

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Updated on 19 February 2024

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cancer

direct bilirubin

cognitive impairment

memantine

central nervous system tumors

effects of radiation therapy

pediatric

Summary

This early phase I trial studies the feasibility of giving memantine for the reduction of cognitive impairment after radiation therapy in pediatric patients with central nervous system tumors. Memantine may reduce the effects of radiation therapy on memory and thinking.

Description

PRIMARY OBJECTIVE:

I. To evaluate the feasibility of twice daily memantine started before radiation therapy (RT) and one month after RT.

SECONDARY OBJECTIVE:

I. To evaluate the feasibility of twice daily (BID) memantine started before RT and continued 3 and 6 months after RT.

EXPLORATORY OBJECTIVES:

I. To evaluate the change in neurocognitive function (NCF) as found by formal neurocognitive testing between baseline and 12 months post-RT.

II. To compare the change in NCF between baseline and the end of RT, 3,and 6 months after RT using both neuropsychological testing and the CogState exam.

III. To evaluate changes in quantitative volumetric brain imaging using Neuroquant software analysis of magnetic resonance imaging (MRI) imaging before and 12 months after radiation.

IV. To correlate cognitive changes detected by CogState composite score and formal neuropsychological testing.

V. Disease-free (of primary tumor) and overall survival.

OUTLINE

Patients receive memantine orally (PO) BID beginning at the time of study enrollment (no later than 1st day of RT) up to 6 months after completion of standard of care RT in the absence of unacceptable toxicity. Patients also complete CogState cognitive testing at baseline, at completion of RT, and at 3, 6, and 12 months after completion of RT.

After completion of study, patients are followed up periodically.

Details

Condition	Malignant Central Nervous System Neoplasm, Primary Central Nervous System Neoplasm
Age	4years - 18years
Treatment	Cogstate Assessment Battery, Memantine, Memantine Hydrochloride
Clinical Study Identifier	NCT04217694
Sponsor	Mayo Clinic
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Receiving intracranial radiation for a primary central nervous system (CNS) malignancy
	Histological or radiologic confirmation of intracranial disease
	Able to use the computer for CogState assessment battery
	Normal serum creatinine per institutional normal limits (obtained =< 35 days prior to study entry)
	Total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN (obtained =< 35 days prior to study entry)
	Aspartate transaminase (AST) AND alanine transaminase (ALT) =< 2.5 x ULN
	Provide informed consent if over age 18, or provide assent with consent from parent or legal guardian if age 7-17
Exclusion Criteria
	Patients with World Health Organization (WHO) grade IV astrocytoma or glioblastoma tumors
	Note: A patient with grade IV tumors of other histology can participate in the study if they meet all other criteria
	Any prior intracranial radiation
	Any contraindication or allergy to memantine
	Use of short-acting benzodiazepines (may excite lethargy/dizziness with memantine)
	Note: occasional use as a sleep aid or as needed for anxiety or nausea is allowed
	Intractable seizures while on adequate anticonvulsant therapy, defined as more than one seizure per month for the past 2 months
	Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
	Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

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Memantine for the Reduction of Cognitive Impairment After Radiation Therapy in Pediatric Patients With Central Nervous System Tumors