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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217694
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Malignant Central Nervous System Neoplasm Primary Central Nervous System Neoplasm Behavioral: Cogstate Assessment Battery Drug: Memantine Drug: Memantine Hydrochloride Early Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study Evaluating the Feasibility of Memantine in Reducing Cognitive Impairment in Pediatric Patients After Radiation Therapy for Central Nervous System Tumors
Actual Study Start Date : May 12, 2020
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prevention (memantine, CogState)
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
Complete CogState testing

Drug: Memantine
Given PO

Drug: Memantine Hydrochloride
Given PO
Other Names:
  • Ebixia
  • Namenda




Primary Outcome Measures :
  1. Percentage of patients who attempt to take appropriate dose of memantine [ Time Frame: At 1 month post-radiation therapy (RT) ]
    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.


Secondary Outcome Measures :
  1. Percentage of patients who attempt to take appropriate dose of memantine [ Time Frame: At 3 and 6 months post-RT ]
    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.



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217694


Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Nadia N. Laack         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Nadia N Laack Mayo Clinic
Additional Information:
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT04217694    
Other Study ID Numbers: MC1911
NCI-2019-08538 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1911 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Cognitive Dysfunction
Neoplasms
Nervous System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neoplasms by Site
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents