Clinical trial · Observational
Brain Function in Children Previously Treated on Clinical Trials POG-9605 and POG-9201
Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201
NCT00028509CI-TRIAL-00013759completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Long-term Effects Secondary to Cancer Therapy in Children | — | UNRESOLVED | — |
| Neurotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| management of therapy complications | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentage of patients with severe intelligence deficit as evidenced by either a verbal or performance IQ below 85
- timeFrame
- Length of study
Secondary outcomes (1)
- measure
- Compare the groups for descriptive purposes
- timeFrame
- Length of study
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 9 Years
Show eligibility criteria text
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 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 PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.