Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor
NCT ID: NCT01381718
Last Updated: 2021-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2011-08-31
2016-08-31
Brief Summary
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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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Detailed Description
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Primary
* 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
* Determine whether modafinil, compared to placebo, is associated with improved executive function, 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 improved attention, as assessed by the Conners' (3rd Edition) 3 Parent Rating Scale (CPRS-3) - Short Form.
* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Arm I
Participants receive modafinil orally (PO) once daily (QD) on days 1-42.
modafinil
Given PO
Arm II
Participants receive placebo PO QD on days 1-42.
placebo
Given PO
Interventions
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modafinil
Given PO
placebo
Given PO
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
19 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Jeffrey P. Krischer, MD, PhD
Role: STUDY_CHAIR
University of South Florida
Nicole J. Ullrich, MD, PhD
Role: STUDY_CHAIR
Boston Children's Hospital
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
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
Children's Hospital Boston
Boston, Massachusetts, United States
CS Mott/University of Michigan
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi
Jackson, Mississippi, United States
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States
Saint Louis University / Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States
Saint Louis University Cancer Center
St Louis, Missouri, United States
Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
New York University Langone Medical Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Doernbecher Children's Hospital/ Oregoon Health Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
East Tennessee Children's Hospital
Knoxville, Tennessee, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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SCUSF-0901
Identifier Type: OTHER
Identifier Source: secondary_id
ACCL0922
Identifier Type: OTHER
Identifier Source: secondary_id
SCUSF 0901
Identifier Type: -
Identifier Source: org_study_id
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