๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-09

A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for a Brain Tumor (NCT04939597)

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Children's Oncology Group

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This phase III trial compares memantine to placebo in treating patients with primary central nervous system tumors. Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary central nervous system tumors.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (17 items) and avoid the listed exclusions (14 items).

Location: Children's Hospital of Alabama โ€” Birmingham, Alabama

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Life expectancy of less than 18 months
  • Pre-existing conditions:
  • Any contraindication or allergy to study drug (memantine or placebo)
  • Intractable seizures while on adequate anticonvulsant therapy, defined as more than one seizure per month for the past 2 months or since initiating anticonvulsant therapy
  • History of neurodevelopmental disorder such as Down syndrome, Fragile X, William's Syndrome, intellectual disability (presumed intelligence quotient \[IQ\] \< 70), etc
  • Co-morbid systemic illnesses, psychiatric conditions, social situations, 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 or would limit compliance with the study requirements
  • Patients with a motor, visual, or auditory condition that precludes participation in computerized neurocognitive assessments
  • Patients with any medical condition or taking medications that lead to alterations of urine pH towards the alkaline condition (e.g., renal tubular acidosis, carbonic anhydrase inhibitors, sodium bicarbonate)
  • Personal history of prior cranial or craniospinal radiotherapy is not allowed
  • Note: Prior anti-cancer therapy including surgery, chemotherapy, targeted agents are allowed as per standard of care clinical treatment guidelines
  • Female patients who are pregnant are excluded since fetal toxicities and teratogenic effects have been noted for the study drug. A pregnancy test is required for female patients of childbearing potential

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (138 Sites)

  • Children's Hospital of Alabama โ€” Birmingham, Alabama
  • Providence Alaska Medical Center โ€” Anchorage, Alaska
  • Banner Children's at Desert โ€” Mesa, Arizona
  • Phoenix Childrens Hospital โ€” Phoenix, Arizona
  • Banner University Medical Center - Tucson โ€” Tucson, Arizona
  • Arkansas Children's Hospital โ€” Little Rock, Arkansas
  • Kaiser Permanente Downey Medical Center โ€” Downey, California
  • Loma Linda University Medical Center โ€” Loma Linda, California
  • Miller Children's and Women's Hospital Long Beach โ€” Long Beach, California
  • Children's Hospital Los Angeles โ€” Los Angeles, California
  • Valley Children's Hospital โ€” Madera, California
  • UCSF Benioff Children's Hospital Oakland โ€” Oakland, California
  • Kaiser Permanente-Oakland โ€” Oakland, California
  • Children's Hospital of Orange County โ€” Orange, California
  • Lucile Packard Children's Hospital Stanford University โ€” Palo Alto, California
  • Rady Children's Hospital - San Diego โ€” San Diego, California
  • UCSF Medical Center-Mission Bay โ€” San Francisco, California
  • Children's Hospital Colorado โ€” Aurora, Colorado
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center โ€” Denver, Colorado
  • Connecticut Children's Medical Center โ€” Hartford, Connecticut
  • Alfred I duPont Hospital for Children โ€” Wilmington, Delaware
  • Children's National Medical Center โ€” Washington D.C., District of Columbia
  • Golisano Children's Hospital of Southwest Florida โ€” Fort Myers, Florida
  • UF Health Cancer Institute - Gainesville โ€” Gainesville, Florida
  • Nemours Children's Clinic-Jacksonville โ€” Jacksonville, Florida

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—