Learning Impairments Among Survivors of Childhood Cancer
6 Years
18 Years
Both
Acute Lymphoblastic Leukemia, Brain Tumors
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:
Interventional
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:
No
Principal Investigator
Heather M Conklin
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Jude Children's Research Hospital
Authority:
United States: Institutional Review Board
Study ID:
MEMFX2
NCT ID:
NCT00576472
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
Name | Location |
|---|---|
| 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 |
