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| Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028509 |
Purpose
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 | Intervention |
|
Cancer-Related Problem/Condition |
Procedure: management of therapy complications |
| MedlinePlus related topics: | Cancer |
| Drug Information available for: | Methotrexate |
| Study Type: | Observational |
| Official Title: | Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201 |
| Estimated Enrollment: | 162 |
| Study Start Date: | July 2002 |
OBJECTIVES:
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.
Eligibility
| Ages Eligible for Study: | 1 Year to 9 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Previously enrolled on POG-9201 or POG-9605
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations |
Show 26 Study Locations |
| Children's Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Patricia K. Duffner, MD | Women and Children's Hospital of Buffalo |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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| Study ID Numbers: | CDR0000069100, COG-ACCL0131, NCI-P01-0198 |
| First Received: | January 4, 2002 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00028509 |
| Health Authority: | United States: Federal Government |
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