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

NCT04217694 | Completed Early Phase 1 DMC FDA Drug

• 3 other identifiers: MC1911NCI-2019-0853819-004245
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Central Nervous System Neoplasm; Primary Central Nervous System Neoplasm

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who attempt to take appropriate dose of memantine

  The rate of feasibility (the percentage of patients who attempt to take at least 80% percent of their prescribed dose) will be calculated, along with corresponding 90% confidence intervals.

  At 1 month post-radiation therapy (RT)

Secondary Outcomes (1)

• Percentage of patients who attempt to take appropriate dose of memantine

  At 3 and 6 months post-RT

Other Outcomes (7)

• Change in neurocognitive function (NCF)

  Baseline up to 12 months post-RT

• Change in NCF - CogState

  Baseline up to 6 months post-RT

• Change in NCF - neuropsychological exam

  Baseline up to 6 months post-RT

Study Arms (1)

Prevention (memantine, CogState)

EXPERIMENTAL

Patients receive memantine 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.

Behavioral: Cogstate Assessment Battery; Drug: Memantine; Drug: Memantine Hydrochloride

Interventions

Cogstate Assessment Battery BEHAVIORAL

Complete CogState testing

Prevention (memantine, CogState)

Memantine DRUG

Given PO

Prevention (memantine, CogState)

Memantine Hydrochloride DRUG

Given PO

Also known as: Ebixia, Namenda

Prevention (memantine, CogState)

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only. Patients capable of childbearing must use adequate contraception

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Memantine

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nadia N. Laack, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: January 3, 2020
• Study Start: February 17, 2020
• Primary Completion: September 15, 2022
• Study Completion: August 12, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

US (1)