A Study to Evaluate the Feasibility of Memantine in Reducing Cognitive Impairment in Pediatric Patients After Radiation Therapy for Central Nervous System Tumors

Overview

NCT ID: NCT04217694
Sponsor Protocol Number: MC1911

About this study

The purpose of this study is to evaluate the feasibility of twice daily memantine started before radiation therapy (RT) and continued one month after radiation therapy (RT), and to evaluate the feasibility of twice daily (BID) memantine started before RT and continued 3 and 6 months after RT.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 4 years to ≤ 18 years old.
  • Receiving intracranial radiation for a primary CNS malignancy.
  • Histological or radiologic confirmation of intracranial disease.
  • Able to use the computer for CogState assessment battery.
  • Serum creatinine and total bilirubin obtained ≤ 35 days prior to study entry, with adequate kidney and liver function defined as follows:
    • Normal serum creatinine per institutional normal limits;
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) OR Direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 x ULN, 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.

Exclusion Criteria:

  • Patients with 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.

 

More information

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CLS-20475817

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