Modafinil in Treating Children with Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor
This randomized phase II trial studies how well modafinil works in treating children with memory and attention problems caused by cancer treatment for a brain tumor. Modafinil may help improve memory, attention, and fatigue caused by cancer treatment.
Inclusion Criteria
- Diagnosis of a primary brain tumor treated with at least one of the following: * Neurosurgical resection of the brain tumor * Cranial irradiation * Any chemotherapy to treat the brain tumor
- Off-treatment and progression-free for at least 12 months and =< 14 years; treatment cessation is defined as the final dose of chemotherapy, the last dose (fraction) of radiation, or date of surgery, whichever occurred last
- Parent/legal guardian and child > 7 years old able to read English or Spanish
- Vision and hearing (eyeglasses and/or hearing aid permissible) sufficient for valid test administration and cooperation with examinations
- 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
- 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 * Childbearing potential is defined as girls who are > Tanner stage 2, except for those who have documented pan pituitary insufficiency or other hormonal state incompatible with pregnancy * Urine pregnancy tests are acceptable
- Able and willing to sign informed consent/assent
- Signed Health Insurance Portability and Accountability Act (HIPAA) compliant research authorization
Exclusion Criteria
- Off treatment > 14 years
- Inability to perform the testing procedure (for example, because of aphasia, motor deficits affecting the dominant hand, or intelligence quotient [IQ] < 70)
- Known cardiac disorders including arrhythmias, hypertension requiring treatment or structural heart disease
- Diagnosis of narcolepsy, sick sinus syndrome, arrhythmia, or prolonged corrected QT interval (QTc)
- History of stroke or head injury associated with loss of consciousness within 12 months of registration
- History of grade 2 depression or anxiety or treatment with antidepressants, antipsychotics or monoamine oxidase inhibitor (MAO) inhibitors within 30 days of registration
- Concurrent treatment with any medications or substances that are potent inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (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, and tricyclic antidepressants * If patients were previously taking EIAEDs, they must be off for > 2 weeks prior to study enrollment
- Treatment with other stimulant medications within 14 days of registration; however, a diagnosis of attention-deficit hyperactivity disorder (ADHD) does NOT exclude a child from participation
- Participants with known hypersensitivity to modafinil, armodafinil, or any of its components
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01381718.
PRIMARY OBJECTIVES:
I. Determine whether a 6-week drug trial of modafinil, compared to placebo, is associated with improvement in neurocognitive function as defined by direct assessment of attention in children with cognitive impairment after treatment for a primary brain tumor.
SECONDARY OBJECTIVES:
I. Determine whether modafinil, compared to placebo, is associated with improved executive function (apart from working memory), as assessed using the Behavior Rating Inventory of Executive Function (BRIEF) executive function and working memory, processing speed, hippocampal learning, and executive function tasks from the CogState battery.
II. Determine whether modafinil, compared to placebo, is associated with reduced fatigue as assessed using the Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale.
III. Evaluate the safety of modafinil in this population.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive modafinil orally (PO) once daily (QD) on days 1-42.
ARM II: Patients receive placebo PO QD on days 1-42.
After completion of study therapy, patients are followed up for 30 days.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationSunCoast CCOP Research Base at the University of South Florida
Principal InvestigatorJeffrey P. Krischer
- Primary IDACCL0922
- Secondary IDsNCI-2011-02594, SCUSF-0901, CDR0000702733, S12-03632, SCUSF 0901
- ClinicalTrials.gov IDNCT01381718