Learning Impairments Among Survivors of Childhood Cancer
Condition: Acute Lymphoblastic Leukemia; Brain Tumors
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Brain Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Children surviving some types of cancer have a higher risk of developing learning problems
      after cancer treatment than do children who have not had cancer or its treatment. Cancer
      treatment may cause problems with learning, attention, and memory. The purpose of this study
      is to identify brain changes that may underlie learning problems in cancer survivors and
      investigate whether methylphenidate (a stimulant medication) may reduce these problems.

      Subjects who have had treatment for acute lymphoblastic leukemia (ALL) or a brain tumor will
      be asked to take part in this research study. Siblings of some subjects will also be asked to
      take part, so that their results can be compared with those of children who have had cancer
      treatment. We hypothesize that children receiving more aggressive therapy will have lower
      white matter brain volumes and these volumes will be significantly lower than age-matched
      siblings. We also hypothesize that children who take methylphenidate will show improvements
      on teacher and parent report measures of attention and social skills.
    

Detailed description: 
      This study is a multi-phase, multi-site methylphenidate (MPH) trial in childhood cancer
      survivors. Study participants that meet inclusion and exclusion criteria are screened to
      ensure that they have adequate global cognitive functioning (IQ > 50) and have academic and
      attention difficulties that might be managed with MPH. Following the screening phase,
      qualifying participants take part in a two-day, in-clinic, double-blind, cross-over trial
      during which they receive MPH (0.6 mg/kg; maximum dose, 20 mg) and placebo (inert substance)
      in a randomly assigned order. Patients who do not have a significant adverse reaction during
      the two-day trial go on to participate in a randomized, double-blind, placebo-controlled,
      three-week home cross-over trial consisting of placebo, low-dose MPH (0.3 mg/kg; maximum
      dose, 10 mg bid), and moderate-dose MPH (0.6 mg/kg; maximum dose, 20 mg bid). Patients are
      then selected for participation in a 12-month open-label MPH trial if they show improvement
      over placebo on a parent and/or teacher rating of attention during the three-week home
      cross-over trial. The 12-month open-label MPH trial includes individually titrated MPH dosing
      to maximize clinical benefit, monthly monitoring of side effects and regular acquisition of
      parent and teacher ratings of attention and behavior. Laboratory measures of intellectual
      function, attention and memory are conducted at the end of the 12-month trial.
    

Intervention name(s): Methylphenidate
Intervention type(s): Drug
Intervention description(s): Please see detailed description for dosing information and study design.
Intervention MeSH terms: Methylphenidate
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Brain Tumor, Acute Lymphoblastic Leukemia, Methylphenidate, Cognitive Late Effects