RATIONALE: Cancer therapies may affect the ability of a child's brain and central nervous system to function normally. Learning to identify which patients will develop complications may improve the ability of doctors to plan cancer treatment and improve patient quality of life.

PURPOSE: Clinical trial to study neurobehavioral changes in children who have received steroid therapy or intrathecal therapy for acute lymphoblastic leukemia.

Condition	Treatment or Intervention
long-term effects secondary to cancer therapy in children neurotoxicity psychosocial effects/treatment childhood acute lymphoblastic leukemia in remission	Procedure: complications of therapy assessment/management  Procedure: psychosocial assessment/care  Procedure: supportive care/therapy

Further Study Details: 

OBJECTIVES:

• Compare neurobehavioral functioning, specifically memory, attention, executive function, visual-motor integration, and processing speed, in children previously treated with steroids (prednisone vs dexamethasone) and intrathecal therapy (methotrexate alone vs methotrexate, cytarabine, and hydrocortisone) for childhood acute lymphoblastic leukemia.
• Correlate non-treatment risk factors, such as gender, age at diagnosis, and time since termination of prior therapy, with impaired neurobehavioral function in these patients.
• Correlate neurobehavioral complications with quality-of-life of these patients.

OUTLINE: This is a multicenter, cohort study. Patients are assigned to 1 of 2 cohorts (prior treatment per CCG-1922 [prednisone vs dexamethasone] vs prior treatment per CCG-1952 [intrathecal (IT) methotrexate vs IT methotrexate, cytarabine, and hydrocortisone]). Patients in each cohort are stratified according to age at diagnosis, gender, and time since prior treatment termination.

• Cohort A (CCG-1922): Patients undergo physical and neurological examination, neurobehavioral evaluation, and quality of life assessment. Neurobehavioral evaluations assess memory, attention, and executive function.
• Cohort B (CCG-1952): Patients undergo evaluation as above. Neurobehavioral evaluations assess visual-motor integration and processing speed.

PROJECTED ACCRUAL: A total of 448 patients (224 per cohort) will be accrued for this study within 4 years.

Ages Eligible for Study:  6 Years   -   16 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of standard-risk childhood acute lymphoblastic leukemia (ALL)
• In continuous first remission
• No history of CNS pathology requiring radiotherapy or surgery
• Prior enrollment on one of the following Children's Cancer Group (CCG) protocols AND terminated therapy at least 1 year ago:
• CCG-1922 (prednisone vs dexamethasone)
• CCG-1952 (intrathecal methotrexate vs triple intrathecal therapy)
• No prior enrollment on CCG-1952 arm III
• No history of pre-existing neurodevelopmental disorder before diagnosis of ALL (e.g., mental retardation, Down syndrome, seizure disorder, or traumatic brain injury)
• No neuropsychological assessment within the past 6 months

PATIENT CHARACTERISTICS: Age

• 6.5 to 16 years

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Reading, speaking, and listening comprehension of English by patient required (English and/or Spanish by parent)
• No history of very low birth weight (< 1,500 grams)

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics

Other

• Concurrent stimulants allowed

California
      Children's Hospital Los Angeles, Los Angeles,  California,  90027-0700,  United States; Recruiting
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States; Recruiting
      Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States; Recruiting
Colorado
      Children's Hospital Cancer Center, Denver,  Colorado,  80218,  United States; Recruiting
Delaware
      Alfred I. duPont Hospital for Children, Wilmington,  Delaware,  19899,  United States; Recruiting
District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  20010-2970,  United States; Recruiting
Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States; Recruiting
Michigan
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0914,  United States; Recruiting
Minnesota
      Children's Hospitals and Clinics - Minneapolis/St. Paul, Minneapolis,  Minnesota,  55404,  United States; Recruiting
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
New York
      NYU Cancer Institute at New York University Medical Center, New York,  New York,  10016,  United States; Recruiting
Ohio
      Cincinnati Children's Hospital Medical Center, Cincinnati,  Ohio,  45229-3039,  United States; Recruiting
      Columbus Children's Hospital, Columbus,  Ohio,  43205-2696,  United States; Recruiting
Oregon
      Doernbecher Children's Hospital at Oregon Health & Science University, Portland,  Oregon,  97239-3098,  United States; Recruiting
Pennsylvania
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
      Children's Hospital of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Tennessee
      Vanderbilt Children's Hospital, Nashville,  Tennessee,  37232-6310,  United States; Recruiting
Texas
      MBCCOP - South Texas Pediatrics, San Antonio,  Texas,  78229-3900,  United States; Recruiting
Utah
      Huntsman Cancer Institute at University of Utah, Salt Lake City,  Utah,  84112,  United States; Recruiting
Washington
      Children's Hospital and Regional Medical Center - Seattle, Seattle,  Washington,  98105,  United States; Recruiting

Study chairs or principal investigators

Nina S. Kadan-Lottick, MD, MSPH,  Study Chair,  Yale Cancer Center   
Joseph P. Neglia, MD, MPH,  University of Minnesota Cancer Center   

Study ID Numbers:  CDR0000367480; COG-ALTE02C2; NCT00085176
Record last reviewed:  May 2004
Last Updated:  March 3, 2005
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00085176
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08