Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor
A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor
4 other identifiers
interventional
112
1 country
60
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2011
Longer than P75 for phase_2
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
August 13, 2021
CompletedAugust 13, 2021
September 1, 2018
5 years
June 23, 2011
April 2, 2021
July 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Age-Adjusted Scores at Week Six From Baseline in the Attention Task of the CogState Battery
CogState Battery. CogState is a semi-automated, computerized cognitive testing system that was developed as a rapid and accurate test of cognitive function specifically for repeated assessment that is sensitive to the effects of medication in children over the age of 5 years and in adults from different language, cultural and socio-economic backgrounds. The CogState tasks to assess processing speed, visual attention, working memory and executive function were used. The CogState battery was administered in the following order: Detection Task, Identification Task, One Card Learning Task, One Back Task, and lastly, the Modified Groton Maze Learning Task. It was administered at baseline and 6 weeks. A positive change from baseline is an improvement. There is not a minimum or maximum since the value is reported as a z-score, but with the mean = 0 and the SD = 1, the range should be between -3 and 3.
Baseline and 6 weeks
Secondary Outcomes (3)
Number of Reported Adverse Events (AEs)
30 days post intervention
Change in Working Memory Score at 6 Weeks From Baseline as Assessed on BRIEF
Baseline and 6 weeks
Change in PedsQL Score at 6 Weeks From Baseline
Baseline and 6 weeks
Study Arms (2)
Arm I
EXPERIMENTALParticipants receive modafinil orally (PO) once daily (QD) on days 1-42.
Arm II
PLACEBO COMPARATORParticipants receive placebo PO QD on days 1-42.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Floridalead
- National Cancer Institute (NCI)collaborator
Study Sites (60)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Miller Children's Hospital
Long Beach, California, 90806, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304, United States
Rady Children's Hospital - San Diego
San Diego, California, 92123, United States
Children's Hospital of Colorado; Saint Joseph Hospital
Denver, Colorado, 80218, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
A. I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970, United States
Lee Memorial Health System
Fort Myers, Florida, 33908, United States
University of Florida
Gainesville, Florida, 32610, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
Nemours Children's Hospital
Orlando, Florida, 32827, United States
Nemours Children's Clinic- Pensacola
Pensacola, Florida, 32207, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
SunCoast CCOP Research Base at the University of South Florida
Tampa, Florida, 33612, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96813, United States
St. Luke's Mountain States Tumor Institute
Boise, Idaho, 83712, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Riley Hospital for Children- Indiana University
Indianapolis, Indiana, 46163, United States
Kosair Children's Hospital
Louisville, Kentucky, 40202, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
CS Mott/University of Michigan
Ann Arbor, Michigan, 48109, United States
Wayne State University
Detroit, Michigan, 48201, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Mississippi
Jackson, Mississippi, 39216, United States
Children's Mercy Hospital and Clinics
Kansas City, Missouri, 64108, United States
Saint Louis University / Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104, United States
Saint Louis University Cancer Center
St Louis, Missouri, 63110, United States
Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
New York University Langone Medical Center
New York, New York, 10016, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, 10032, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Dayton Children's Hospital
Dayton, Ohio, 45404, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Doernbecher Children's Hospital/ Oregoon Health Science University
Portland, Oregon, 97329, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19320, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
East Tennessee Children's Hospital
Knoxville, Tennessee, 37916, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507, United States
St. Vincent Hospital
Green Bay, Wisconsin, 54301, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nicole J. Ullrich, MD, PhD
- Organization
- Children's Hospital Boston/Harvard Medical School
Study Officials
- STUDY CHAIR
Jeffrey P. Krischer, MD, PhD
University of South Florida
- STUDY CHAIR
Nicole J. Ullrich, MD, PhD
Boston Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2011
First Posted
June 27, 2011
Study Start
August 1, 2011
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 13, 2021
Results First Posted
August 13, 2021
Record last verified: 2018-09