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Brain and Central Nervous System TumorsPhase 2NCT01381718

Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor

A Phase 2 study testing modafinil in people with Brain and Central Nervous System Tumors and Cognitive/Functional Effects, run by University of South Florida at 60 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 6 to 19 years
What is being tested?
modafinil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
60 sitesUnited States
Study dates
Aug 2011to Aug 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

United States60 sites

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • CS Mott/University of Michigan

    Ann Arbor, Michigan, 48109

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • St. Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Children's Hospital Boston

    Boston, Massachusetts, 02115

  • University of Virginia

    Charlottesville, Virginia, 22908

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • Dayton Children's Hospital

    Dayton, Ohio, 45404

  • Children's Hospital of Colorado; Saint Joseph Hospital

    Denver, Colorado, 80218

  • Wayne State University

    Detroit, Michigan, 48201

  • Lee Memorial Health System

    Fort Myers, Florida, 33908

  • University of Florida

    Gainesville, Florida, 32610

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96813

  • Riley Hospital for Children- Indiana University

    Indianapolis, Indiana, 46163

  • University of Mississippi

    Jackson, Mississippi, 39216

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • Children's Mercy Hospital and Clinics

    Kansas City, Missouri, 64108

  • East Tennessee Children's Hospital

    Knoxville, Tennessee, 37916

  • Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Miller Children's Hospital

    Long Beach, California, 90806

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • Kosair Children's Hospital

    Louisville, Kentucky, 40202

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • Children's Hospitals and Clinics of Minnesota

    Minneapolis, Minnesota, 55404

  • Vanderbilt Children's Hospital

    Nashville, Tennessee, 37232

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • New York University Langone Medical Center

    New York, New York, 10016

  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    New York, New York, 10032

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nemours Children's Hospital

    Orlando, Florida, 32827

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California, 94304

  • Nemours Children's Clinic- Pensacola

    Pensacola, Florida, 32207

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19320

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

  • Doernbecher Children's Hospital/ Oregoon Health Science University

    Portland, Oregon, 97329

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123

  • Saint Louis University / Cardinal Glennon Children's Medical Center

    St Louis, Missouri, 63104

  • Saint Louis University Cancer Center

    St Louis, Missouri, 63110

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Tampa General Hospital

    Tampa, Florida, 33606

  • SunCoast CCOP Research Base at the University of South Florida

    Tampa, Florida, 33612

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

  • A. I. duPont Hospital for Children

    Wilmington, Delaware, 19803

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor

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.

Read the detailed 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.

Being tested
modafinil, placebo
Keywords
childhood brain tumor, neurotoxicity, fatigue, cognitive/functional effects, psychosocial effects of cancer and its treatment
Medical subject headings
Central Nervous System Neoplasms, Fatigue, Neurotoxicity Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • modafinilDrug

    Given PO

  • placeboOther

    Given PO

Study groups in NCT01381718
Study groupRoleWhat they receive
Arm IExperimentalParticipants receive modafinil orally (PO) once daily (QD) on days 1-42.
Receives: Drug: modafinil
Arm IIPlacebo comparatorParticipants receive placebo PO QD on days 1-42.
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 6 weeks

Secondary outcomes (3)

  1. Number of Reported Adverse Events (AEs)

    AEs gathered using SAFTEE (Systematic Assessment for Treatment Emergent Effects) and participant report on daily log.

    Measured: 30 days post intervention

  2. 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.

    Measured: Baseline and 6 weeks

  3. 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.

    Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01381718
Sponsor's protocol ID
SCUSF 0901
Other IDs
SCUSF-0901, ACCL0922, 5U10CA081920-11
Status last verified
Sep 2018
First submitted
23 Jun 2011
Last updated
13 Aug 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing modafinil in people with Brain and Central Nervous System Tumors and Cognitive/Functional Effects, run by University of South Florida at 60 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Age-Adjusted Scores at Week Six From Baseline in the Attention Task of the CogState Battery (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01381718.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.

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