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

Completed · Phase 2 · Has a placebo group

Conditions studied: Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Fatigue, Neurotoxicity, Psychosocial Effects of Cancer and Its Treatment

In brief

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.

Key facts

Study ID

NCT01381718

Run by

University of South Florida

People needed

112

Starts

2011-08-01

Expected to finish

2016-08-01

Last updated by the study team

2021-08-13

Who can join

Age: 6 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 6 years and ≤ 18 years 10 months at the time of study entry (so that participants will be < 19 at the 6 week evaluation, which is the upper age limit for which the included instruments are valid).
• Diagnosis of a primary brain tumor treated with at least one of the following:
• neurosurgical resection of the brain tumor;
• cranial irradiation; or
• 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 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.

You may not qualify if…

• Off treatment > 14 years
• Inability to perform the testing procedure (for example, because of aphasia, motor deficits affecting the dominant hand, or IQ < 70)
• Known cardiac disorders including arrhythmias, hypertension requiring treatment or structural heart disease
• Diagnosis of narcolepsy, sick sinus syndrome, arrhythmia or prolonged 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 MAO inhibitors within 30 days of registration
• 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.
• 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 ADHD does NOT exclude a child from participation
• Participants with known hypersensitivity to modafinil, armodafinil or any of its components

Where it is running

• Miller Children's Hospital — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• Children's Hospital of Colorado; Saint Joseph Hospital — Denver, Colorado, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• A. I. duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Lee Memorial Health System — Fort Myers, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Nemours Children's Hospital — Orlando, Florida, United States
• Nemours Children's Clinic- Pensacola — Pensacola, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• SunCoast CCOP Research Base at the University of South Florida — Tampa, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
• St. Luke's Mountain States Tumor Institute — Boise, Idaho, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Riley Hospital for Children- Indiana University — Indianapolis, Indiana, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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