Current Research Studies

ACCL2031, 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, Memantine & NeuroCog CNS Tumors study

What is the goal of the study?

Radiotherapy (RT) is a proven curative therapeutic tool for the treatment of primary brain tumors in children. However, the effect of cerebral RT on long-term cognitive function is a major concern.1 Neuropsychological assessments in this population have consistently demonstrated measurable deficits and declines over time. Numerous studies have identified 40 to 100% of childhood brain tumor survivors with some cognitive deficits resulting from disease and/or treatments.2-4 Preventing cognitive dysfunction and identifying agents or methods for neuroprotection is one of the most compelling questions in this population. Although recent efforts suggest modest benefit from interventions used in post-treatment setting to treat neurocognitive deficits in children previously treated for a primary brain tumor, memantine is the only agent with pre-clinical and clinical evidence supporting the possibility to prevent cognitive dysfunction resulting from cranial irradiation. The recent adult trial (RTOG 0614) suggests prevention of neurocognitive effects is possible with the concurrent use of memantine during whole brain radiation without impact on tumor control. Based on the results of the adult study and the mechanism of action, we hypothesize that memantine will prevent excitotoxicity, and therefore microvascular injury and neuronal loss, and resulting cognitive decline in pediatric patients receiving cranial radiotherapy. ACCL2031 is a Phase 3, placebo-controlled randomized clinical trial in children receiving cranial/craniospinal RT for primary brain tumors to evaluate whether memantine prevents cognitive decline. Through use of a computerized testing battery and an optional, COG Standardized Neuropsychological and Behavioral Battery (COG Standardized Battery) at both early and later timepoints, the study will measure the developmental trajectory of neurocognitive function after cranial irradiation at both early (3, 6, and 12 months) and later (30 and 60 months) timepoints to establish a framework for further neuro-protection trials. In addition, this study will correlate changes in cognitive function to radiation dosimetry and radiographic changes by quantitative MRI analysis.

Who can participate in the study?

Please contact the study team listed below to learn more.

Study Team: