Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information
Brain Function in Children Previously Treated on Clinical Trials POG-9605 and POG-9201
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Natural history/Epidemiology | Completed | 1 to 9 at diagnosis | NCI | COG-ACCL0131 NCI-P01-0198, NCT00028509, ACCL0131 |
Objectives
- Compare the incidence of neuropsychological abnormalities and leukoencephalopathy in children previously treated with methotrexate on protocols POG-9605 versus POG-9201.
Entry Criteria
Disease Characteristics:
- Previously enrolled on POG-9201 or POG-9605
- Good prognosis by NCI risk (9201 and 9605 stratum 1)
- Eligible for the therapeutic study
- Completed therapy by 12/31/2000
- No CNS3 at diagnosis
- No relapsed disease
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- See Disease Characteristics
Patient Characteristics:
Age:
- 1 to 9 at diagnosis
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No Down syndrome
Expected Enrollment
162A 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.
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.
Trial Lead Organizations
Children's Oncology Group
 | | | ||
| Patricia Duffner, MD, Protocol chair | |
| ||
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Related Information
PDQ® clinical trial POG-9201
PDQ® clinical trial POG-9605
| Registry Information | ||
| ||
| Official Title | Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201 | |
| ||
| Trial Start Date | 2002-07-29 | |
| ||
| Trial Completion Date | 2011-07-01 | |
| ||
| Registered in ClinicalTrials.gov | NCT00028509 | |
| ||
| Date Submitted to PDQ | 2001-10-18 | |
| ||
| Information Last Verified | 2010-11-12 | |
| ||
| NCI Grant/Contract Number | CA13539, CA30969, CA37400 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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