Trial Search Results
Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy
RATIONALE: Methylphenidate hydrochloride or modafinil may help reduce daytime sleepiness and improve the quality of life of patients with excessive daytime sleepiness after cancer therapy. It is not yet known whether methylphenidate hydrochloride or modafinil are more effective than a placebo in reducing daytime sleepiness in these patients.
PURPOSE: This randomized phase II trial is studying methylphenidate hydrochloride or modafinil to see how well they work compared with a placebo in treating young patients with excessive daytime sleepiness after cancer therapy.
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
University of South Florida
Collaborator: National Cancer Institute (NCI)
Stanford Investigator(s):
Intervention(s):
- Drug: methylphenidate hydrochloride
- Drug: modafinil
- Drug: placebo
Phase:
Phase 2
Eligibility
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).
Ages Eligible for Study
8 Years - 18 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting