Evaluating Memantine for Neurocognitive Protection in Children Undergoing Cranial Radiotherapy as Part of Treatment for Primary Central Nervous System Tumors
A Phase III Randomized, Placebo-Controlled Trial Evaluating Memantine for Neurocognitive Protection in Children Undergoing Cranial Radiotherapy as Part of Treatment for Primary Central Nervous System Tumors
About
Protocol Description
The overall goal of this study is to see if taking memantine compared to taking a placebo for 6 months makes a difference in cognitive function for children receiving radiation therapy as part of standard treatment for a brain tumor. The trial will also study results from cognitive function tests, brain images and lab tests in children and adolescents taking memantine compared to children and adolescents taking a placebo.
COG# ACCL2031
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed or recurrent primary brain tumors that have not received prior cranial radiotherapy.
- Age ≥4 and <18 years at time of study entry
- Patients must weigh 15 kg or greater at time of study entry.
- Treatment plan is for planned focal, cranial or craniospinal radiation treatment for a primary brain tumor.
- Patient must have receptive and expressive language skills in English, French or Spanish, because the neurocognitive function and quality-of-life assessment instruments are available in these languages only.
- Adequate renal and liver function as defined the by protocol.
- Patient must be able to undergo magnetic resonance imaging (MRI).
Exclusion Criteria
- History of prior cranial or craniospinal radiotherapy is not allowed.
- Life expectancy of less than 18 months.
- Any contraindication or allergy to memantine.
- Pre-existing conditions as defined the by protocol.
- Pregnant or lactating female patients are not allowed.
See Protocol Section 3 for a complete comprehensive list of inclusion and exclusion criteria.
Primary Investigator
Dr. Glenn Edwards is the section chief of Pediatric Hematology/Oncology, as well as the Children's Oncology Group's principal investigator for Carilion Clinic. He has over 30 years of clinical experience and is is board certified by the American Board of Pediatrics in Pediatrics and Pediatric Hematology/Oncology. He completed his fellowship at Walter Reed Army Medical Center and completed his internship and residency at Tripler Army Medical Center.
Contact Information
Wendy McCarty, C.C.R.P.
Clinical Research Coordinator II