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A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor
Protocol Number:
Phase II
Kenneth Cohen
Johns Hopkins Kimmel Cancer Center in Baltimore
This phase II randomized trial studies how well modafinil works in treating children with memory and attention problems caused by cancer treatment for a brain tumor.
Ages Eligible for Study: 6 Years to 17 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria INCLUSION CRITERIA: â?¢Age â?¥ 6 years and â?¤ 17 years 10 months at the time of study entry (so that participants will be less than 18 at the 6 week evaluation, which is the upper age limit for which the included instruments are valid). â?¢Diagnosis of a primary brain tumor treated with at least one of the following: a.neurosurgical resection of the brain tumor; b.cranial irradiation; or c.any chemotherapy to treat the brain tumor. â?¢Off-treatment and progression-free for at least 12 months and â?¤ 84 months. Treatment cessation is defined as the final dose of chemotherapy, the last dose (fraction) of radiation or date of surgery, whichever occurred last. â?¢Parent/Legal Guardian and child able to read English. â?¢Vision and hearing (eyeglasses and/or hearing aid permissible) sufficient for valid test administration and cooperation with examinations. â?¢Availability of a reliable parent or legal guardian who is willing and able to complete all of the outcome measures and fulfill the requirements of the study, including administration of medications and accompanying the participant to all study visits. â?¢Females of childbearing potential must have a negative pregnancy test result and must agree to use a medically acceptable method of contraception throughout the entire study period and for 30 days after the last dose of study drug. â?¢Childbearing potential is defined as girls who are greater than Tanner stage 2, except for those who have documented pan pituitary insufficiency or other hormonal state incompatible with pregnancy. â?¢Urine pregnancy tests are acceptable. EXCLUSION CRITERIA: â?¢Off treatment greater than 84 months â?¢Inability to perform the testing procedure (for example, because of aphasia, motor deficits affecting the dominant hand, or IQ less than 70) â?¢Known cardiac disorders including arrhythmias, hypertension requiring treatment or structural heart disease â?¢Diagnosis of narcolepsy, sick sinus syndrome, arrhythmia or prolonged QTc â?¢History of stroke or head injury associated with loss of consciousness within 12 months of registration â?¢History of grade 2 depression or anxiety or treatment with antidepressants, antipsychotics or MAO inhibitors within 30 days of registration â?¢Concurrent treatment with any medications or substances that are potent inhibitors or inducers of CYP3A4, hepatic enzyme inducing antiepileptic drugs (EIAEDs),or other drugs known to affect the metabolism of modafinil. Examples include but are not limited to itraconazole, ketoconazole, doxycycline, rifampin, St. John's wort, phenytoin, phenobarbital, diazepam, tricyclic antidepressants. â?¢If patients were previously taking, EIAEDs, they must be off for greater than 2 weeks prior to study enrollment. â?¢Treatment with other stimulant medications within 14 days of registration; however, a diagnosis of ADHD does NOT exclude a child from participation â?¢Participants with known hypersensitivity to modafinil, armodafinil or any of its components
This is a multicenter study. Participants are randomized to 1 of 2 treatment arms. â?¢Arm I: Participants receive modafinil orally (PO) once daily (QD) on days 1-42. â?¢Arm II: Participants receive placebo PO QD on days 1-42. Participants complete a semi-automated, computerized cognitive-testing system (CogState) designed to assess psychomotor, attention/vigilance, memory, and other components of executive function by presenting different tasks, each with its own set of rules, at baseline and after completion of study therapy. Participants also complete the PedsQL Multidimensional Fatigue Scale (Peds QL-MFS). Parents or legal guardians complete the PedsQL-MFS, the Conners Parent Reported Scale (CPR-3), and the Behavior Rating Inventory of Executive Function (BRIEF) at baseline and after completion of study therapy. Clinical and/or research staff administer the Systematic Assessment for Treatment Emergency Events (SAFTEE), a semi-structured interview designed to elicit adverse events, at baseline and periodically during study. After completion of study therapy, participants are followed up for 30 days.
Last Update
08/08/2020 05:02 AM