Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor

Status: Recruiting
Phase: Phase 2
Diagnosis: Pediatric Brain Tumor
NCT ID: NCT01381718 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-025

 

RATIONALE: Modafinil may help improve memory, attention, and fatigue caused by cancer treatment. PURPOSE: 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.

 

Conducting Institutions:
Children's Hospital Boston, Dana-Farber Cancer Institute

Overall PI:
Nicole Ullrich, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

DISEASE CHARACTERISTICS: - 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 ≥ 12 months and ≤ 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 PATIENT CHARACTERISTICS: - Parent/legal guardian and child able to read English - 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 - No inability to perform the testing procedure (for example, because of aphasia, motor deficits affecting the dominant hand, or IQ < 70) - No known cardiac disorders including arrhythmias, hypertension requiring treatment or structural heart disease - No diagnosis of narcolepsy, sick sinus syndrome, arrhythmia, or prolonged QTc - No history of stroke or head injury associated with loss of consciousness within the past 12 months - No history of grade 2 depression or anxiety - No participants with known hypersensitivity to modafinil, armodafinil, or any of its components PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No treatment with antidepressants, antipsychotics, or MAO inhibitors within 30 days of registration - No concurrent treatment with any medications or substances that are potent inhibitors or inducers of CYP3A4, including hepatic enzyme-inducing antiepileptic drugs (EIAEDs) - If patients were previously taking EIAEDs, they must be off for > 2 weeks prior to study enrollment - No treatment with other stimulant medications within 14 days of registration; however, a diagnosis of ADHD does NOT exclude a child from participation
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