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SCUSF 0901 A Phase II Placebo-controlled trial of modafinil to improve neurocognitive deficits in children treated for a primary brain tumor (ACCL0922)

Study Chair:
Nicole Ullrich, MD, Ph.D.
 
Status:
Approved by NCI
Activation Date: 8/15/2011
NCT01381718

Study Objectives

The primary objective of this study is to 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.

The secondary objectives of this study are to:

  • 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 PedQL Multidimensional Fatigue Scale
  • Evaluate the saftey of modafinil in this population

Inclusion Criteria

  • Age between 8 years and 17 years 10 months at the time of screening (so that participants will be less than 18 at the 6 week evaluation, which is the upper age for which the included instruments are valid)
  • Diagnosis of a primary brain tumor treated with at least one of the following: (a) neurosurgical resection of the brain tumor; (b) cranial irradiation; or (c) any chemotherapy to treat the brain tumor
  • Off-treatment and progression-free for at least 12 months and less than or equal to 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.
  • Vision and hearing (eyeglasses and/or hearing aid permissible) sufficient for valid test administration and cooperation with examinations.

Exclusion Criteria

  • Age between 6 and 17 years 10 months at the time of study entry (so that participants will be less that 18 years of age 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: (a) neurosurgical resection of the brain tumor; (b) cranial irradiation; or (c) any chemotherapy to treat the brain tumor.
  • Off-treatment and progression-free for at least 12 months and less than 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.
  • 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.
  • Able and willing to sign informed consent/assent.
  • Signed HIPAA compliant research authorization.

Exclusion Criteria:

  • Patients with metastatic disease
  • Off treatment > 84 months (See protocol section 5.1.3 for definition of off-treatment)
  • 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.
    (see protocol section 7.2.18 Appendix IV for lists of specifically prohibited medications or substances)
    • 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

 

Link to Abstract [.pdf]

Please note, this information may change if the protocol is amended. Please refer to the current protocol for the most accurate information such as a complete list of the eligibility requirements.

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