Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01381718 : Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor
PhasePhase 2
AgesMin: 6 Years Max: 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
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT01381718      |      Link to official Clinicaltrials.gov listing
Locations
Birmingham, Alabama
Facility: University of Alabama at Birmingham
Investigator: Alyssa Reddy, MD
Contact: Vicky L. Poss Phone: 205-939-5430
Email not avaialable

Long Beach, California
Facility: Miller Children's Hospital
Investigator: Amanda Termuhlen, MD
Contact: Devin Murphy, MSW Phone: 562-933-8626
Email not avaialable

Los Angeles, California
Facility: Children's Hospital Los Angeles
Investigator: David R Freyer
Contact: Diana Palma Phone: 323-361-5973
Email not avaialable

Palo Alto, California
Facility: Lucile Packard Children's Hospital Stanford University
Investigator: Neyssa Marina, MD
Contact: Jennifer Lew Phone: 650-725-4318
Email not avaialable

San Diego, California
Facility: Rady Children's Hospital - San Diego
Investigator: William Roberts, MD
Contact: Neera Gundrania Phone: 858-966-8823
Email not avaialable

Denver, Colorado
Facility: Children's Hospital of Colorado; Saint Joseph Hospital
Investigator:
Contact: Jenny Madden, RN MSN CPNP Phone: 720-777-3407
Email not avaialable

Hartford, Connecticut
Facility: Connecticut Children's Medical Center
Investigator: Michael Isakoff, MD
Contact: Robin Arens, CCRP Phone: 860-545-9614
Email not avaialable

Wilmington, Delaware
Facility: A. I. duPont Hospital for Children
Investigator: E. Anders Kolb, MD
Contact: Ande Wrightson Phone: 302-651-5584
Email not avaialable

Washington, District of Columbia
Facility: Children's National Medical Center
Investigator:
Contact: Clinical Trials Office - Children's National Medical Center Phone: 202-884-2549
Email not avaialable

Fort Myers, Florida
Facility: Lee Memorial Health System
Investigator: Emad Salman, MD
Contact: Molly Arnstrom, RN Phone: 239-343-6959
Email not avaialable

Gainesville, Florida
Facility: University of Florida
Investigator: William Slayton, MD
Contact: Gigi Moore-Higgs, ARNP, PhD Phone: 352-273-9050
Email not avaialable

Hollywood, Florida
Facility: Joe DiMaggio Children's Hospital
Investigator: Iftikhar Hanif, MD
Contact: Nuria Garantiva Phone: 954-265-6513
Email not avaialable

Jacksonville, Florida
Facility: Nemours Children's Clinic
Investigator: Eric Sandler, MD
Contact: Ingrid Ingram Phone: 904-697-3985
Email not avaialable

Orlando, Florida
Facility: Nemours Children's Hospital
Investigator: Ramamoorthy Nagasubramanian, MD
Contact: Kristen Gibbs Phone: 407-650-7652
Email not avaialable

Pensacola, Florida
Facility: Nemours Children's Clinic- Pensacola
Investigator: Scott Bradfield, MD
Contact: Dannah McCormick Phone: 850-505-4794
Email not avaialable

St. Petersburg, Florida
Facility: All Children's Hospital
Investigator: Gregory Hale, MD
Contact: Jennifer Flanary, RN BSN Phone: 727-767-6466
Email not avaialable

Tampa, Florida
Facility: Tampa General Hospital
Investigator: Cameron Tebbi, MD
Contact: Denise Fife, RN Phone: 813-844-7829
Email not avaialable

Tampa, Florida
Facility: SunCoast CCOP Research Base at the University of South Florida
Investigator:
Contact: Jeffrey P. Krischer, MD, PhD Phone: 813-979-6706
Email not avaialable

Atlanta, Georgia
Facility: Children's Healthcare of Atlanta
Investigator: Tobey MacDonald, MD
Contact: Ashley Griffin Phone: 404-785-0653
Email not avaialable

Honolulu, Hawaii
Facility: Kapiolani Medical Center for Women and Children
Investigator: Robert Wilkinson, MD
Contact: Annette Amiotte Phone: 808-983-6386
Email not avaialable

Boise, Idaho
Facility: St. Luke's Mountain States Tumor Institute
Investigator: Eugenia Chang, MD
Contact: Tammie Eslinger Phone: 208-381-2774
Email not avaialable

Chicago, Illinois
Facility: University of Illinois at Chicago
Investigator: Mary Lou Schmidt, MD
Contact: Johnathan Davidson Phone: 312-355-2936
Email not avaialable

Indianapolis, Indiana
Facility: Riley Hospital for Children- Indiana University
Investigator: Robert Fallon, MD
Contact: Shannon Maraldo Phone: 317-948-3395
Email not avaialable

Louisville, Kentucky
Facility: Kosair Children's Hospital
Investigator: Kanyalakshimi Ayyanar, MD
Contact: Belinda Coy Phone: 502-852-2915
Email not avaialable

Baltimore, Maryland
Facility: Johns Hopkins University
Investigator: Kenneth Cohen, MD
Contact: Tammy Scott, RN Phone: 410-614-5990
Email not avaialable

Boston, Massachusetts
Facility: Children's Hospital Boston
Investigator:
Contact: Clinical Trials Office - Children's Hospital Boston Phone: 800-828-6622
Email not avaialable

Ann Arbor, Michigan
Facility: CS Mott/University of Michigan
Investigator: Rama Jasty, MD
Contact: Joyce Satarino Phone: 734-763-6344
Email not avaialable

Detroit, Michigan
Facility: Wayne State University
Investigator: Zhihong (Joanne) Wang, MD PhD
Contact: Laura Strathdee Phone: 313-966-7918
Email not avaialable

Minneapolis, Minnesota
Facility: Children's Hospitals and Clinics of Minnesota
Investigator: Bruce Bostrom, MD
Contact: Nicole Hart Phone: 612-813-5940
Email not avaialable

Rochester, Minnesota
Facility: Mayo Clinic
Investigator: Amulya NageswaraRao, MD
Contact: Sharon Bell Phone: 507-284-8871
Email not avaialable

Jackson, Mississippi
Facility: University of Mississippi
Investigator: Gail Megason, MD
Contact: Dana Cole, RN CPON Phone: 601-984-2712
Email not avaialable

Kansas City, Missouri
Facility: Children's Mercy Hospital and Clinics
Investigator: Maxine Hetherington, MD
Contact: Karen Ollek Phone: 816-460-1043
Email not avaialable

Saint Louis, Missouri
Facility: Saint Louis University Cancer Center
Investigator:
Contact: Clinical Trials Office - Saint Louis University Cancer Center Phone: 314-977-4440
Email not avaialable

St. Louis, Missouri
Facility: Saint Louis University / Cardinal Glennon Children's Medical Center
Investigator: William S. Ferguson, MD
Contact: Donna Marin Phone: 314-268-4029
Email not avaialable

Las Vegas, Nevada
Facility: Nevada Cancer Research Foundation
Investigator: Alan Ikeda, MD
Contact: Valerie Littlefield Phone: 702-384-0013
Email not avaialable

Hackensack, New Jersey
Facility: Hackensack University Medical Center
Investigator: Stephen J Thompson, MD
Contact: Cheryl Falls, CRC Phone: 551-996-5619
Email not avaialable

New Brunswick, New Jersey
Facility: Saint Peter's University Hospital
Investigator: Stanley Calderwood, MD
Contact: Monique Tabachri Phone: 732-745-6674
Email not avaialable

Albuquerque, New Mexico
Facility: University of New Mexico
Investigator: Koh Boayue, MD
Contact: Meredith Russell, CCRP Phone: 505-272-6419
Email not avaialable

Bronx, New York
Facility: Montefiore Medical Center
Investigator:
Contact: Peter Cole, MD Phone: 718-741-2338
Email not avaialable

New York, New York
Facility: Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
Investigator:
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C Phone: 212-305-8615
Email not avaialable

New York City, New York
Facility: New York University Langone Medical Center
Investigator: Jeffrey C Allen, MD
Contact: Anna Yaffe Phone: 212-263-9945
Email not avaialable

Syracuse, New York
Facility: SUNY Upstate Medical University
Investigator: Karol Kerr, MD
Contact: Karen Bilynsky Phone: 315-464-7601
Email not avaialable

Winston-Salem, North Carolina
Facility: Wake Forest University Health Sciences
Investigator: Sharon Castellino, MD
Contact: Graham Keyes Phone: 336-716-9027
Email not avaialable

Akron, Ohio
Facility: Children's Hospital Medical Center of Akron
Investigator: Steven Kuerbitz, MD
Contact: Jill Bradisse Phone: 330-543-3805
Email not avaialable

Dayton, Ohio
Facility: Dayton Children's Hospital
Investigator: Emmett Broxson, Jr., MD
Contact: Debra Cunningham, RN Phone: 937-641-3432
Email not avaialable

Oklahoma City, Oklahoma
Facility: University of Oklahoma Health Sciences Center
Investigator: Rene McNall, MD
Contact: Christina Gonzalez, CCRP Phone: 405-271-4412
Email not avaialable

Portland, Oregon
Facility: Doernbecher Children's Hospital/ Oregoon Health Science University
Investigator: Kellie Nazemi, MD
Contact: Lisa Dodgen Phone: 503-418-2394
Email not avaialable

Philadelphia, Pennsylvania
Facility: Children's Hospital of Philadelphia
Investigator:
Contact: Carol Armstrong, PhD Phone: 215-590-1709
Email not avaialable

Philadelphia, Pennsylvania
Facility: St. Christopher's Hospital for Children
Investigator:
Contact: Akash Nahar, MD Phone: 215-427-6805
Email not avaialable

Pittsburgh, Pennsylvania
Facility: Children's Hospital of Pittsburgh of UPMC
Investigator: Regina Jakacki, MD
Contact: Melanie Gieraltowski Phone: 412-692-8089
Email not avaialable

Knoxville, Tennessee
Facility: East Tennessee Children's Hospital
Investigator: Ray C Pais, MD
Contact: Barbara Bush, RN Phone: 865-541-8617
Email not avaialable

Memphis, Tennessee
Facility: St. Jude Children's Research Hospital
Investigator: Amar Gajjar, MD
Contact: Annemarie McClennan, MS CCRA Phone: 901-595-2734
Email not avaialable

Nashville, Tennessee
Facility: Vanderbilt Children's Hospital
Investigator: Adam Esbenshade, MD
Contact: Cheryl Edens, CCRP Phone: 615-936-1762
Email not avaialable

Corpus Christi, Texas
Facility: Driscoll Children's Hospital
Investigator: Cris Johnson, MD
Contact: Claire Hollek Phone: 361-694-4439
Email not avaialable

Dallas, Texas
Facility: Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Investigator:
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a Phone: 866-460-4673
Email not avaialable

San Antonio, Texas
Facility: University of Texas Health Science Center at San Antonio
Investigator:
Contact: Leanne Embry, PhD Phone: 210-704-2987
Email not avaialable

Charlottesville, Virginia
Facility: University of Virginia
Investigator:
Contact: Colleen H. Druzgal, MD Phone: 434-924-5105
Email not avaialable

Green Bay, Wisconsin
Facility: St. Vincent Hospital
Investigator: John Hill, MD
Contact: Christy Gilchrist Phone: 920-433-8272
Email not avaialable

Milwaukee, Wisconsin
Facility: Midwest Children's Cancer Center
Investigator: Paul Harker-Murray, MD, PhD
Contact: Malini Shankar Phone: 414-266-2012
Email not avaialable




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