Title: A phase 3 randomized, placebo-controlled trial evaluating memantine for neurocognitive protection in children undergoing cranial radiotherapy as part of treatment for primary central nervous system tumors

Principal Investigator: Nadia N. Laack, MD, of Children’s Oncology Group

Description: Researchers are conducting a phase 3 trial to determine if oral memantine hydrochloride (memantine) can protect neurocognitive function in pediatric patients receiving cranial or craniospinal radiotherapy for primary central nervous system (CNS) tumors.


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Patients will be randomly assigned to receive memantine or placebo twice daily until disease progression, unacceptable toxicity, or the 24-week mark. Patients in both arms will complete cognitive testing over 20-30 minutes at baseline, the end of radiotherapy, 3 months, 6 months, 12 months, 30 months, and 60 months.

The primary outcome measure is the Cogstate composite Z score. Secondary outcome measures include scores for IQ, processing speed, verbal memory, visual memory, and other neurocognitive outcomes, as well as disease-free survival and overall survival.

To be eligible for this study, patients must be 4 to 17 years of age. They must have newly diagnosed or recurrent primary brain tumors and have not received prior cranial radiotherapy. They must also have receptive and expressive language skills in English, French, or Spanish. For a full list of eligibility criteria, please see the reference.

Status: Recruiting

This study is sponsored by Children’s Oncology Group.

Reference

ClinicalTrials.gov. A study to see if memantine protects the brain during radiation therapy treatment for a brain tumor. NCT04939597. Accessed July 19, 2022.