A Phase 3 Study of Memantine to Protect the Brain in Children Receiving Radiation Therapy for a Brain Tumor

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Full Title

A Phase 3 Randomized, Placebo-Controlled Trial Evaluating Memantine (IND# 149832) for Neurocognitive Protection in Children Undergoing Cranial Radiotherapy as Part of Treatment for Primary Central Nervous System Tumors (ACCL2031) (CIRB)

Purpose

In this study, researchers are comparing the drug memantine to a placebo (inactive drug) in children and teens receiving radiation therapy for a brain tumor. Memantine may block receptors (parts of nerve cells) in the brain that contribute to a decline in cognitive function (attention, memory, or other thought processes). Giving memantine may help preserve cognitive function in young patients receiving radiation therapy as part of their treatment for a primary brain tumor.

Participants will be randomly assigned to receive memantine or a placebo. Cognitive function will be assessed at the beginning of the study, at the end of radiation therapy, and every several months for up to five years. Memantine is taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must be planning to receive radiation therapy for a brain tumor that is newly diagnosed or came back after prior treatment.
  • Previous radiation therapy to the brain is not permitted.
  • Participants must speak and understand English, French, or Spanish.
  • This study is for people ages 4 to 17 years old.

Contact

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

22-440

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT04939597