This randomized pilot phase II trial studies how well memantine hydrochloride works in preventing cognitive decline in pediatric patients with brain or germ cell tumors that have not spread to other parts of the body undergoing radiation therapy. Memantine hydrochloride may enhance cognitive function by binding to and inhibiting channels of receptors located in the central nervous system.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03194906.
PRIMARY OBJECTIVES:
I. To estimate the participation rate in a study of memantine hydrochloride (memantine) used as a neuro-protective agent in children undergoing radiotherapy for localized brain tumors (low grade glioma, craniopharyngioma, ependymoma, meningioma, or germ cell tumor).
II. To estimate the rate of memantine medication adherence.
III. To estimate the rate of completion of cognitive assessments.
SECONDARY OBJECTIVES:
I. To estimate the effect size of change in neurobehavioral outcomes (cognitive, social, quality of life, neurologic) associated with memantine.
II. To evaluate the frequency and nature of memantine side effects as measured by the Systematic Assessment for Treatment Emergent Events (SAFTEE).
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo radiation therapy for 6 weeks and receive memantine hydrochloride orally (PO) twice daily (BID) for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
GROUP II: Patients undergo radiation therapy for 6 weeks and receive placebo PO BID for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 9 months.
Lead OrganizationSaint Jude Children's Research Hospital
Principal InvestigatorHeather M. Conklin
