Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy

INCLUSION CRITERIA:

   - Patient and family must agree to return to the clinic up to 8 times within 2 months

   - Children ≥ 8 and <18 years of age at the time of study entry who were previously
   treated for:

   - a hypothalamic tumor

   - mid-line brain tumor

   - a tumor involving one or both thalami

   - craniopharyngioma

   - diagnosis of hydrocephalus secondary to a brain tumor or treatment of a brain tumor
   that required placement of a permanent shunt.

   - Off cancer treatment for at least six months

   - Proficient in English

   - Able to swallow capsules

   - Experiencing symptoms of excessive daytime sleepiness (EDS) for at least three months
   prior to study entry that is not a result of inadequate sleep hygiene or other known
   medical disorder.

   - Negative pregnancy test

EXCLUSION CRITERIA:

   - Patients treated with doxorubicin or high dose cyclophosphamide

   - History of a clinically significant drug sensitivity to methylphenidate, modafinil,
   armodafinil or any of their components

   - Known cardiac disorders including arrhythmias, hypertension requiring treatment or
   structural heart disease

   - Have taken methylphenidate or modafinil within the last 14 days

   - Current/concurrent use of antihistamines, benzodiazepine, anticonvulsants or alcohol

   - Clinical diagnosis of major depression, subclinical depression, or anxiety disorder

   - History of psychosis or mania

   - Patients with suicidal ideation

   - Diagnosis with anemia, untreated hypothyroidism, mononucleosis or narcolepsy

   - History of substance abuse

   - Pregnant or breast feeding

   - A total dietary intake of more than 500 mg of caffeine per day (e.g., approximately
   ten 330 mL cans of soft drinks, five cups of coffee or tea, or 750 g chocolate per
   day).