Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor
Conditions
Brain and Central Nervous System Tumors - Cognitive/Functional Effects - Fatigue - Neurotoxicity - Psychosocial Effects of Cancer and Its Treatment
Conditions: official terms
Brain Neoplasms - Central Nervous System Neoplasms - Nervous System Neoplasms - Neurotoxicity Syndromes
Conditions: Keywords
childhood brain tumor, neurotoxicity, fatigue, cognitive/functional effects, psychosocial effects of cancer and its treatment
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Intervention
Name: modafinil Type: Drug
Name: placebo Type: Other
Overall Status
Recruiting
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.
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 parent report of inattention or working memory deficits or by direct assessment of attention, working memory, or processing speed 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 (apart from working memory), 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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 19 Years
Minimum Age: 6 Years
Gender: Both
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
Locations
University of Alabama at Birmingham
Birmingham, Alabama, United States
Status: Recruiting
Contact: Vicky L. Poss - 205-939-5430
Miller Children's Hospital
Long Beach, California, United States
Status: Recruiting
Contact: Devin Murphy, MSW - 562-933-8626
Children's Hospital Los Angeles
Los Angeles, California, United States
Status: Recruiting
Contact: Diana Palma - 323-361-5973
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States
Status: Recruiting
Contact: Jennifer Lew - 650-725-4318
University of California San Francisco
San Francisco, California, United States
Status: Withdrawn
Children's Hospital of Colorado; Saint Joseph Hospital
Denver, Colorado, United States
Status: Recruiting
Contact: Jenny Madden, RN MSN CPNP - 720-777-3407
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Status: Recruiting
Contact: Robin Arens, CCRP - 860-545-9614
Children's National Medical Center
Washington, District of Columbia, United States
Status: Recruiting
Contact: Clinical Trials Office - Children's National Medical Center - 202-884-2549
Lee Memorial Health System
Fort Myers, Florida, United States
Status: Recruiting
Contact: Molly Arnstrom, RN - 239-343-6959
University of Florida
Gainesville, Florida, United States
Status: Recruiting
Contact: Gigi Moore-Higgs, ARNP, PhD - 352-273-9050
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Status: Recruiting
Contact: Nuria Garantiva - 954-265-6513
Nemours Children's Clinic
Jacksonville, Florida, United States
Status: Recruiting
Contact: Ingrid Ingram - 904-697-3985
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
Status: Withdrawn
Nemours Children's Hospital
Orlando, Florida, United States
Status: Recruiting
Contact: Kristen Gibbs - 407-650-7652
Nemours Children's Clinic- Pensacola
Pensacola, Florida, United States
Status: Recruiting
Contact: Dannah McCormick - 850-505-4794
All Children's Hospital
St. Petersburg, Florida, United States
Status: Recruiting
Contact: Jennifer Flanary, RN BSN - 727-767-6466
SunCoast CCOP Research Base at the University of South Florida
Tampa, Florida, United States
Status: Recruiting
Contact: Jeffrey P. Krischer, MD, PhD - 813-979-6706
Tampa General Hospital
Tampa, Florida, United States
Status: Recruiting
Contact: Denise Fife, RN - 813-844-7829
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Status: Recruiting
Contact: Ashley Griffin - 404-785-0653
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Annette Amiotte - 808-983-6386
St. Luke's Mountain States Tumor Institute
Boise, Idaho, United States
Status: Recruiting
Contact: Tammie Eslinger - 208-381-2774
University of Illinois at Chicago
Chicago, Illinois, United States
Status: Recruiting
Contact: Johnathan Davidson - 312-355-2936
Riley Hospital for Children- Indiana University
Indianapolis, Indiana, United States
Status: Recruiting
Contact: Shannon Maraldo - 317-948-3395
Kosair Children's Hospital
Louisville, Kentucky, United States
Status: Recruiting
Contact: Belinda Coy - 502-852-2915
Johns Hopkins University
Baltimore, Maryland, United States
Status: Recruiting
Contact: Tammy Scott, RN - 410-614-5990
Children's Hospital Boston
Boston, Massachusetts, United States
Status: Recruiting
Contact: Clinical Trials Office - Children's Hospital Boston - 800-828-6622
CS Mott/University of Michigan
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Joyce Satarino - 734-763-6344
Wayne State University
Detroit, Michigan, United States
Status: Recruiting
Contact: Laura Strathdee - 313-966-7918
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
Status: Recruiting
Contact: Nicole Hart - 612-813-5940
Mayo Clinic
Rochester, Minnesota, United States
Status: Recruiting
Contact: Sharon Bell - 507-284-8871
University of Mississippi
Jackson, Mississippi, United States
Status: Recruiting
Contact: Dana Cole, RN CPON - 601-984-2712
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States
Status: Recruiting
Contact: Karen Ollek - 816-460-1043
Saint Louis University Cancer Center
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Clinical Trials Office - Saint Louis University Cancer Center - 314-977-4440
Hackensack University Medical Center
Hackensack, New Jersey, United States
Status: Recruiting
Contact: Cheryl Falls, CRC - 551-996-5619
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
Status: Recruiting
Contact: Monique Tabachri - 732-745-6674
University of New Mexico
Albuquerque, New Mexico, United States
Status: Recruiting
Contact: Meredith Russell, CCRP - 505-272-6419
Montefiore Medical Center
Bronx, New York, United States
Status: Recruiting
Contact: Peter Cole, MD - 718-741-2338
New York University Langone Medical Center
New York City, New York, United States
Status: Recruiting
Contact: Anna Yaffe - 212-263-9945
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States
Status: Recruiting
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C - 212-305-8615
SUNY Upstate Medical University
Syracuse, New York, United States
Status: Recruiting
Contact: Karen Bilynsky - 315-464-7601
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Status: Recruiting
Contact: Graham Keyes - 336-716-9027
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Status: Recruiting
Contact: Jill Bradisse - 330-543-3805
Dayton Children's Hospital
Dayton, Ohio, United States
Status: Recruiting
Contact: Debra Cunningham, RN - 937-641-3432
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Status: Recruiting
Contact: Christina Gonzalez, CCRP - 405-271-4412
Doernbecher Children's Hospital/ Oregoon Health Science University
Portland, Oregon, United States
Status: Recruiting
Contact: Lisa Dodgen - 503-418-2394
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Carol Armstrong, PhD - 215-590-1709
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Akash Nahar, MD - 215-427-6805
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Contact: Melanie Gieraltowski - 412-692-8089
East Tennessee Children's Hospital
Knoxville, Tennessee, United States
Status: Recruiting
Contact: Barbara Bush, RN - 865-541-8617
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Status: Recruiting
Contact: Annemarie McClennan, MS CCRA - 901-595-2734
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Status: Recruiting
Contact: Cheryl Edens, CCRP - 615-936-1762
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Status: Recruiting
Contact: Claire Hollek - 361-694-4439
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Status: Recruiting
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a - 866-460-4673
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Status: Recruiting
Contact: Leanne Embry, PhD - 210-704-2987
University of Virginia
Charlottesville, Virginia, United States
Status: Recruiting
Contact: Colleen H. Druzgal, MD - 434-924-5105
St. Vincent Hospital
Green Bay, Wisconsin, United States
Status: Recruiting
Contact: Christy Gilchrist - 920-433-8272
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Status: Recruiting
Contact: Malini Shankar - 414-266-2012
Start Date
August 2011
Sponsors
University of South Florida
Source
University of South Florida
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page