Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor
Condition: Brain and Central Nervous System Tumors; Cognitive/Functional Effects; Fatigue; Neurotoxicity; Psychosocial Effects of Cancer and Its Treatment
MeSH terms: Brain Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Neurotoxicity Syndromes; Fatigue
Intervention: modafinil; placebo
Intervention description: Given PO; Given PO
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 6 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: childhood brain tumor; neurotoxicity; fatigue; cognitive/functional effects; psychosocial effects of cancer and its treatment

Summary:

      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.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  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:

               1. neurosurgical resection of the brain tumor;

               2. cranial irradiation; or

               3. 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.

        EXCLUSION CRITERIA:

          -  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