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.

Condition	Treatment or Intervention
neurotoxicity long-term effects secondary to cancer therapy in children	Procedure: complications of therapy assessment/management  Procedure: supportive care/therapy

Further Study Details: 

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.

Ages Eligible for Study:  1 Year   -   9 Years,  Genders Eligible for Study:  Both

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

Colorado
      Children's Hospital Cancer Center, Denver,  Colorado,  80218,  United States; Recruiting
Florida
      Baptist-South Miami Regional Cancer Program, Miami,  Florida,  33176-2197,  United States; Recruiting
      Jackson Memorial Hospital, Miami,  Florida,  33136,  United States; Recruiting
      Joe DiMaggio Children's Hospital at Memorial, Hollywood,  Florida,  33021,  United States; Recruiting
      Miami Children's Hospital, Miami,  Florida,  33155,  United States; Recruiting
      St. Mary's Hospital, West Palm Beach,  Florida,  33407,  United States; Recruiting
Georgia
      MBCCOP-Medical College of Georgia Cancer Center, Augusta,  Georgia,  30912-4000,  United States; Recruiting
Louisiana
      Children's Hospital of New Orleans, New Orleans,  Louisiana,  70118,  United States; Recruiting
      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Michigan
      Children's Hospital of Michigan, Detroit,  Michigan,  48201,  United States; Recruiting
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States; Recruiting
New Jersey
      Cancer Center at Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States; Recruiting
New York
      SUNY Upstate Medical University Hospital, Syracuse,  New York,  13210,  United States; Recruiting
      Women and Children's Hospital of Buffalo, Buffalo,  New York,  14222,  United States; Recruiting
North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
South Carolina
      Hollings Cancer Center at Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States; Recruiting
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
      MBCCOP - South Texas Pediatrics, San Antonio,  Texas,  78229-3900,  United States; Recruiting
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78207,  United States; Recruiting
Utah
      Huntsman Cancer Institute at University of Utah, Salt Lake City,  Utah,  84112,  United States; Recruiting
Washington
      Madigan Army Medical Center, Tacoma,  Washington,  98431-0001,  United States; Recruiting
Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting
      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States; Recruiting
      Midwest Children's Cancer Center, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
Australia, South Australia
      Women's and Children's Hospital, North Adelaide,  South Australia,  5006,  Australia; Recruiting

Study chairs or principal investigators

Patricia K. Duffner, MD,  Study Chair,  Women and Children's Hospital of Buffalo   

Study ID Numbers:  CDR0000069100; COG-ACCL0131; NCI-P01-0198; NCT00028509
Record last reviewed:  August 2003
Last Updated:  April 4, 2005
Record first received:  January 4, 2002
ClinicalTrials.gov Identifier:  NCT00028509
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08