Learning Impairments Among Survivors of Childhood Cancer
Condition: Acute Lymphoblastic Leukemia; Brain Tumors
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Brain Neoplasms
Intervention: Methylphenidate
Intervention description: Please see detailed description for dosing information and study design.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 469.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Brain Tumor, Acute Lymphoblastic Leukemia, Methylphenidate, Cognitive Late Effects

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 6 to 18 years old.

          -  Active subject at St. Jude Children's Research Hospital, or is an age-matched sibling
             control subject.

          -  If a subject, received treatment for brain tumor or ALL with either radiation therapy
             and/or chemotherapy directed at the brain.

          -  If a subject, at least 12 months post-completion of antineoplastic therapies

          -  If a subject, no evidence of malignancy, or continuously stable disease since
             completion of therapy

          -  English as a primary language

          -  Informed consent

        Exclusion Criteria:

          -  Glaucoma

          -  Patient or immediate family member with a history of Tourette's syndrome

          -  Current antidepressant, anxiolytic, antipsychotic or stimulant therapy

          -  History of substance abuse

          -  Recent history of uncontrolled seizures

          -  Uncorrected hypothyroidism

          -  Previously or currently randomized on COGRM1 intervention arm

          -  Previously diagnosed with ADHD, or, if a patient, diagnosed with ADHD prior to
             diagnosis of malignancy