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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of South Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01381718
First received: June 23, 2011
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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 Intervention 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

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

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Change in age-adjusted scores at week six from baseline in any of the 5 questionnaires [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and toxicity of modafinil [ Time Frame: 30 days post intervention ] [ Designated as safety issue: Yes ]
  • Improved executive function (apart from working memory) as assessed by BRIEF and CogState [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Reduced fatigue as assessed by PedsQL [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 228
Study Start Date: August 2011
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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 ≤ 84 months. 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 > 84 months
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381718

  Show 53 Study Locations
Sponsors and Collaborators
University of South Florida
Investigators
Study Chair: Jeffrey P. Krischer, MD, PhD University of South Florida
Study Chair: Nicole J. Ullrich, MD, PhD Children's Hospital Boston
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01381718     History of Changes
Other Study ID Numbers: SCUSF 0901, SCUSF-0901, ACCL0922, 5U10CA081920-11
Study First Received: June 23, 2011
Last Updated: August 19, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

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
Nervous System Neoplasms
Central Nervous System Neoplasms
Brain Neoplasms
Neurotoxicity Syndromes
Neoplasms
Signs and Symptoms
Neoplasms by Site
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Modafinil
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014