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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01381718
Other study ID # SCUSF 0901
Secondary ID SCUSF-0901ACCL09
Status Completed
Phase Phase 2
First received
Last updated
Start date August 2011
Est. completion date August 2016

Study information

Verified date September 2018
Source University of South Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

OBJECTIVES: 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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 6 Years to 19 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
modafinil
Given PO
Other:
placebo
Given PO

Locations

Country Name City State
United States Children's Hospital Medical Center of Akron Akron Ohio
United States University of New Mexico Albuquerque New Mexico
United States CS Mott/University of Michigan Ann Arbor Michigan
United States Children's Healthcare of Atlanta Atlanta Georgia
United States Johns Hopkins University Baltimore Maryland
United States University of Alabama at Birmingham Birmingham Alabama
United States St. Luke's Mountain States Tumor Institute Boise Idaho
United States Children's Hospital Boston Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States University of Virginia Charlottesville Virginia
United States University of Illinois at Chicago Chicago Illinois
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 Dayton Children's Hospital Dayton Ohio
United States Children's Hospital of Colorado; Saint Joseph Hospital Denver Colorado
United States Wayne State University Detroit Michigan
United States Lee Memorial Health System Fort Myers Florida
United States University of Florida Gainesville Florida
United States St. Vincent Hospital Green Bay Wisconsin
United States Hackensack University Medical Center Hackensack New Jersey
United States Connecticut Children's Medical Center Hartford Connecticut
United States Joe DiMaggio Children's Hospital Hollywood Florida
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Riley Hospital for Children- Indiana University Indianapolis Indiana
United States University of Mississippi Jackson Mississippi
United States Nemours Children's Clinic Jacksonville Florida
United States Children's Mercy Hospital and Clinics Kansas City Missouri
United States East Tennessee Children's Hospital Knoxville Tennessee
United States Nevada Cancer Research Foundation Las Vegas Nevada
United States Miller Children's Hospital Long Beach California
United States Children's Hospital Los Angeles Los Angeles California
United States Kosair Children's Hospital Louisville Kentucky
United States St. Jude Children's Research Hospital Memphis Tennessee
United States Midwest Children's Cancer Center Milwaukee Wisconsin
United States Children's Hospitals and Clinics of Minnesota Minneapolis Minnesota
United States Vanderbilt Children's Hospital Nashville Tennessee
United States Saint Peter's University Hospital New Brunswick New Jersey
United States Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York New York
United States New York University Langone Medical Center New York New York
United States Children's Hospital of The King's Daughters Norfolk Virginia
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nemours Children's Hospital Orlando Florida
United States Lucile Packard Children's Hospital Stanford University Palo Alto California
United States Nemours Children's Clinic- Pensacola Pensacola Florida
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 Doernbecher Children's Hospital/ Oregoon Health Science University Portland Oregon
United States Mayo Clinic Rochester Minnesota
United States Saint Louis University / Cardinal Glennon Children's Medical Center Saint Louis Missouri
United States Saint Louis University Cancer Center Saint Louis Missouri
United States All Children's Hospital Saint Petersburg Florida
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Rady Children's Hospital - San Diego San Diego California
United States SUNY Upstate Medical University Syracuse New York
United States SunCoast CCOP Research Base at the University of South Florida Tampa Florida
United States Tampa General Hospital Tampa Florida
United States Children's National Medical Center Washington District of Columbia
United States A. I. duPont Hospital for Children Wilmington Delaware
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of South Florida National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of Reported Adverse Events (AEs) AEs gathered using SAFTEE (Systematic Assessment for Treatment Emergent Effects) and participant report on daily log. 30 days post intervention
Secondary Change in Working Memory Score at 6 Weeks From Baseline as Assessed on BRIEF Behavior Rating Inventory of Executive Function (BRIEF). The BRIEF is a behavior rating scale designed to assess executive functions in the home and school environments. The measure was selected to provide parent-reported outcomes of problems related to attention, memory and executive function that occur in everyday life. The instrument was utilized to measure the change in working memory, according to the parent's perspective only, from baseline to 6 weeks. Scores are linear transformations of raw scores into T scores (mean = 50, SD = 10); higher scores indicate greater difficulties. The baseline score was subtracted from the 6 week score. Positive change from baseline is an improvement. The total scale ranges from 0 to 172. A T score >60 on the BRIEF working memory subscale indicates cognitive impairment. Baseline and 6 weeks
Secondary Change in PedsQL Score at 6 Weeks From Baseline PedsQL is Pediatric Quality of Life Inventory Multi-dimensional Fatigue Scale. This scale is designed as a generic symptom-specific instrument to measure fatigue. Higher scores indicate fewer symptoms of fatigue. It was administered at baseline and 6 weeks. The score is the sum of the answers. The baseline score was subtracted from the 6 week score. A positive change indicates worsening. The scale total score range is from 0-72 for both the parent and patient reported instruments. Baseline and 6 weeks
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