| Conditions: |
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Brain and Central Nervous System Tumors - Cognitive/Functional Effects - Fatigue - Neurotoxicity - Psychosocial Effects of Cancer and Its Treatment |
| Purpose: |
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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.
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| Study Summary: |
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OBJECTIVES:
Primary
- Determine whether a 6-week drug trial of modafinil, compared to placebo, is associated
with improvement in neurocognitive function as defined by parent report of inattention
or working memory deficits or by direct assessment of attention, working memory, or
processing speed in children with cognitive impairment after treatment for a primary
brain tumor.
Secondary
- Determine whether modafinil, compared to placebo, is associated with improved executive
function (apart from working memory), as assessed using the BRIEF executive function
and hippocampal learning and executive function tasks from the CogState battery.
- Determine whether modafinil, compared to placebo, is associated with reduced fatigue as
assessed using the PedsQL Multidimensional Fatigue Scale.
- Evaluate the safety of modafinil in this population.
OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 treatment arms.
- Arm I: Participants receive modafinil orally (PO) once daily (QD) on days 1-42.
- 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.
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| Criteria: |
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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)
- Examples include, but are not limited to, itraconazole, ketoconazole,
doxycycline, rifampin, St. John wort, phenytoin, phenobarbital, diazepam, or
tricyclic antidepressants
- 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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| NCT ID: |
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NCT01381718 |
| Primary Contact: |
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Study Chair
Jeffrey P. Krischer, MD, PhD
University of Florida
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| Backup Contact: |
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N/A |
| Location Contact: |
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Dallas, Texas 75390
United States
Clinical Trials Office - Simmons Comprehensive Cancer Center a
Phone: 866-460-4673; 214-648-7097
Site Status: Recruiting |