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Completed

NCT Number: NCT00028509

Brain Function in Children Previously Treated on Clinical Trials POG-9605 and POG-9201

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.

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Key information

Conditions

Long-term Effects Secondary to Cancer Therapy in Children Chemically-Induced Disorders Nervous System Diseases Neurotoxicity Neurotoxicity Syndromes Poisoning

Age range

1 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

management of therapy complications

Procedure

Primary outcomes

  1. Percentage of patients with severe intelligence deficit as evidenced by either a verbal or performance IQ below 85

    Time frame: Length of study

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201

Important dates

Study start
2002
Primary completion
2011
First posted
Jan 27, 2003
Registry last updated
Feb 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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