Brain Function in Children Previously Treated on Clinical Trials POG-9605 and POG-9201
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|ClinicalTrials.gov Identifier: NCT00028509|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 13, 2014
RATIONALE: Assessing the effects of methotrexate on brain function in children may improve the ability to plan treatment and decrease side effects.
PURPOSE: Clinical trial to compare brain function of children who have been previously treated with methotrexate.
|Condition or disease||Intervention/treatment|
|Long-term Effects Secondary to Cancer Therapy in Children Neurotoxicity||Procedure: management of therapy complications|
- Compare the incidence of neuropsychological abnormalities and leukoencephalopathy in children previously treated with methotrexate on protocols POG-9605 versus POG-9201.
OUTLINE: This is a multicenter study.
More than 3 years after completion of therapy, patients undergo 9 different tests to assess intelligence, memory, learning, attention, concentration, processing of information, functioning, and visual-motor integration. Patients also undergo MRI of the head.
PROJECTED ACCRUAL: A total of 30-54 patients previously treated on protocol POG-9201 will be accrued for this study. A total of 60-108 patients previously treated on protocol POG-9605 will be accrued for this study.
|Study Type :||Observational|
|Actual Enrollment :||66 participants|
|Official Title:||Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201|
|Study Start Date :||July 2002|
|Actual Primary Completion Date :||July 2011|
- Percentage of patients with severe intelligence deficit as evidenced by either a verbal or performance IQ below 85 [ Time Frame: Length of study ]
- Compare the groups for descriptive purposes [ Time Frame: Length of study ]Quantitative scales: IQ (WISC III or WPPSI-R, depending on the age of the child), Wide Range Assessment of Memory and Learning (4 subscales), Conner's Continuous Performance Test (Attention/Concentration), Woodcock Johnson Revised Processing Speed Cluster, NEPSP Tower Tests (Executive Functioning), and VSI (Visual-Motor Integration).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028509
|Study Chair:||Patricia K. Duffner, MD||Women & Children's Hospital of Buffalo|