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

Children's Oncology Group

Status: Completed

Conditions: Neurotoxicity; Long-term Effects Secondary to Cancer Therapy in Children

Treatments: Procedure: management of therapy complications

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00028509

COG-ACCL0131 (Other Identifier)

CDR0000069100 (Other Identifier)

NCI-P01-0198

ACCL0131

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 1 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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