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Learning Impairments Among Survivors of Childhood Cancer

Phase 4
6 Years
18 Years
Open (Enrolling)
Acute Lymphoblastic Leukemia, Brain Tumors

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Trial Information

Learning Impairments Among Survivors of Childhood Cancer

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Brain White Matter Volume for Patients Versus Sibling Controls

Outcome Description:

To compare the white matter volume of patients with those of sibling controls using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study.

Outcome Time Frame:

Enrollment to evaluation of MRI, on average 12.8 months.

Safety Issue:


Principal Investigator

Heather M Conklin

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital


United States: Institutional Review Board

Study ID:




Start Date:

January 2000

Completion Date:

March 2013

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Brain Tumors
  • Brain Tumor, Acute Lymphoblastic Leukemia, Methylphenidate, Cognitive Late Effects
  • Brain Neoplasms
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



Medical University of South Carolina Charleston, South Carolina  29425-0721
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Duke University Medical Center Durham, North Carolina  27710