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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00028509

Enrollment

Registered

2003-01-27

Start date

2002-07-31

Completion date

Unknown

Last updated

2014-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-term Effects Secondary to Cancer Therapy in Children, Neurotoxicity

Keywords

neurotoxicity, long-term effects secondary to cancer therapy in children

Brief summary

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.

Detailed description

OBJECTIVES: * 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.

Interventions

PROCEDUREmanagement of therapy complications

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 9 Years

Healthy volunteers

Inclusion 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 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

Design outcomes

Primary

Measure	Time frame
Percentage of patients with severe intelligence deficit as evidenced by either a verbal or performance IQ below 85	Length of study

Secondary

Measure	Time frame	Description
Compare the groups for descriptive purposes	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).

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026