Sponsor
St. Jude Children's Research Hospital
Status
Completed
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT03194906
Children with brain tumors who have had radiation therapy are at risk for problems with attention, memory, and problem solving. Such problems may cause difficulty in school and daily life. Memantine, the drug being used for this study, is not yet approved for use in children by the U.S. Food and Drug Administration. However, studies have shown some improvements in memory for patients with dementia, Attention Deficit Hyperactivity Disorder, and autism. Scientists have also used this medication for adult cancer patients receiving radiation therapy with results showing less cognitive declines over time compared to patients taking a placebo (inactive pill). These studies have also shown few side effects.
This is a pilot/feasibility study and the first known study involving children with a cancer diagnosis or brain tumor.
PRIMARY OBJECTIVES:
To estimate the participation rate in a study of memantine used as a neuro-protective agent in children undergoing radiotherapy for localized brain tumors (low grade glioma, craniopharyngioma, ependymoma, or germ cell tumor)
To estimate the rate of memantine medication adherence
To estimate the rate of completion of cognitive assessments
SECONDARY OBJECTIVES:
To estimate the effect size of change in neurobehavioral outcomes (cognitive, social, quality of life, neurologic) associated with memantine
To evaluate the frequency and nature of memantine side effects as measured by the Systematic Assessment for Treatment Emergent Events (SAFTEE)
This is a pilot/feasibility study and the first known study involving children with a cancer diagnosis or brain tumor.
PRIMARY OBJECTIVES:
To estimate the participation rate in a study of memantine used as a neuro-protective agent in children undergoing radiotherapy for localized brain tumors (low grade glioma, craniopharyngioma, ependymoma, or germ cell tumor)
To estimate the rate of memantine medication adherence
To estimate the rate of completion of cognitive assessments
SECONDARY OBJECTIVES:
To estimate the effect size of change in neurobehavioral outcomes (cognitive, social, quality of life, neurologic) associated with memantine
To evaluate the frequency and nature of memantine side effects as measured by the Systematic Assessment for Treatment Emergent Events (SAFTEE)
Intervention
Placebo, Cognitive Assessment, Memantine
Condition
Glioma of Brain, Craniopharyngioma, Ependymoma, Germ Cell Tumor
Investigators
Heather M. Conklin, PhD