ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01381718
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida

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.


Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Cognitive/Functional Effects Fatigue Neurotoxicity Psychosocial Effects of Cancer and Its Treatment Drug: modafinil Other: placebo Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor
Study Start Date : August 2011
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016


Arm Intervention/treatment
Experimental: Arm I
Participants receive modafinil orally (PO) once daily (QD) on days 1-42.
Drug: modafinil
Given PO

Placebo Comparator: Arm II
Participants receive placebo PO QD on days 1-42.
Other: placebo
Given PO




Primary Outcome Measures :
  1. Change in age-adjusted scores at week six from baseline in the attention task of the CogState battery [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Safety and toxicity of modafinil [ Time Frame: 30 days post intervention ]
  2. Improved executive function (apart from working memory) as assessed by BRIEF and CogState [ Time Frame: 6 weeks ]
  3. Reduced fatigue as assessed by PedsQL [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381718


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
Miller Children's Hospital
Long Beach, California, United States, 90806
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
United States, Colorado
Children's Hospital of Colorado; Saint Joseph Hospital
Denver, Colorado, United States, 80218
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, Delaware
A. I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, D.C., District of Columbia, United States, 20010-2970
United States, Florida
Lee Memorial Health System
Fort Myers, Florida, United States, 33908
University of Florida
Gainesville, Florida, United States, 32610
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Nemours Children's Clinic- Pensacola
Pensacola, Florida, United States, 32207
All Children's Hospital
Saint Petersburg, Florida, United States, 33701
Tampa General Hospital
Tampa, Florida, United States, 33606
SunCoast CCOP Research Base at the University of South Florida
Tampa, Florida, United States, 33612
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
United States, Hawaii
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96813
United States, Idaho
St. Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Indiana
Riley Hospital for Children- Indiana University
Indianapolis, Indiana, United States, 46163
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Michigan
CS Mott/University of Michigan
Ann Arbor, Michigan, United States, 48109
Wayne State University
Detroit, Michigan, United States, 48201
United States, Minnesota
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi
Jackson, Mississippi, United States, 39216
United States, Missouri
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108
Saint Louis University / Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, United States, 63104
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
United States, Nevada
Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
New York University Langone Medical Center
New York, New York, United States, 10016
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Montefiore Medical Center
The Bronx, New York, United States, 10467
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Doernbecher Children's Hospital/ Oregoon Health Science University
Portland, Oregon, United States, 97329
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19320
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
East Tennessee Children's Hospital
Knoxville, Tennessee, United States, 37916
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232
United States, Texas
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
United States, Wisconsin
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of South Florida
National Cancer Institute (NCI)
Investigators
Study Chair: Jeffrey P. Krischer, MD, PhD University of South Florida
Study Chair: Nicole J. Ullrich, MD, PhD Boston Children’s Hospital

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01381718     History of Changes
Other Study ID Numbers: SCUSF 0901
SCUSF-0901 ( Other Identifier: SunCoast CCOP Research Base )
ACCL0922 ( Other Identifier: Children's Oncology Network )
5U10CA081920-11 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by University of South Florida:
childhood brain tumor
neurotoxicity
fatigue
cognitive/functional effects
psychosocial effects of cancer and its treatment

Additional relevant MeSH terms:
Fatigue
Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neurotoxicity Syndromes
Signs and Symptoms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Modafinil
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs