Neurobehavioral Complications in Children Who Were Previously Treated With Steroids and Intrathecal Therapy for Acute Lymphoblastic Leukemia
Condition: Leukemia; Long-term Effects Secondary to Cancer Therapy in Children; Neurotoxicity; Psychosocial Effects of Cancer and Its Treatment
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Neurotoxicity Syndromes
Study type: Observational

Summary: 
      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: This clinical trial is studying neurobehavioral changes in children who have
      received steroid therapy or intrathecal therapy for acute lymphoblastic leukemia.
    

Detailed description: 
      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.
    

Intervention name(s): management of therapy complications; psychosocial assessment and care
Intervention type(s): Procedure; Procedure
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children previously randomized to (1) dexamethasone instead of prednisone on COG 1922 and
        (2) intrathecal methotrexate, cytarabine, and hydrocortisone (triple therapy) instead of
        intrathecal methotrexate alone on COG 1952
      
Keywords: long-term effects secondary to cancer therapy in children; neurotoxicity; psychosocial effects of cancer and its treatment; childhood acute lymphoblastic leukemia in remission