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Neurobehavioral Complications in Children Who Were Previously Treated With Steroids and Intrathecal Therapy for Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00085176
First Posted: June 11, 2004
Last Update Posted: January 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose

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.


Condition Intervention
Leukemia Long-term Effects Secondary to Cancer Therapy in Children Neurotoxicity Psychosocial Effects of Cancer and Its Treatment Procedure: management of therapy complications Procedure: psychosocial assessment and care

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Neurobehavioral Outcomes in Childhood Acute Lymphoblastic Leukemia. A Limited Non-Therapeutic Study

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Two-sided comparisons of various mean neurobehavioral scores between the two treatment arms within each study [ Time Frame: length of study ]
    Data analysis for each of the two clinical trials will be conducted separately. The primary objectives will be two-sided comparisons of various mean neurobehavioral scores between the two treatment arms within each study.


Enrollment: 286
Study Start Date: May 2004
Study Completion Date: January 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085176


  Show 31 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Nina S. Kadan-Lottick, MD, MSPH Yale University
Study Chair: Joseph P. Neglia, MD, MPH Masonic Cancer Center, University of Minnesota
  More Information

Publications:
Lindemulder SJ, Stork LC, Bostrom BC, et al.: Trends in body mass index (BMI) during and after treatment for standard risk (SR) acute lymphoblastic leukemia (ALL): A report from the Children's Oncology Group (COG). [Abstract] J Clin Oncol 30 (Suppl 15): A-9546, 2012.
Breiger D, Kaleita TA, Kadan-Lottick NS, et al.: Behavioral social adjustment in survivors of childhood acute lymphoblastic leukemia (ALL) treated without cranial radiation. [Abstract] Pediatr Blood Cancer 46 (6): A-3505.43, 690, 2006.
Kadan-Lottick NS, Brouwers P, Kaleita TA, et al.: Preliminary findings of neurobehavioral outcomes in survivors of childhood acute lymphoblastic leukemia (ALL) treated without cranial radiation. [Abstract] Pediatr Blood Cancer 46 (6): A-3505.45, 691, 2006.
Kadan-Lottick NS, Stork LC, Bostrom BC, et al.: Increased prevalence of overweight status in survivors of acute lymphoblastic leukemia (ALL) treated without cranial radiation . [Abstract] Pediatr Blood Cancer 46 (6): A-3505.44, 690, 2006.

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00085176     History of Changes
Other Study ID Numbers: ALTE02C2
COG-ALTE02C2 ( Other Identifier: Children's Oncology Group )
CDR0000367480 ( Other Identifier: Clinicaltrials.gov )
First Submitted: June 10, 2004
First Posted: June 11, 2004
Last Update Posted: January 30, 2014
Last Verified: January 2014

Keywords provided by Children's Oncology Group:
long-term effects secondary to cancer therapy in children
neurotoxicity
psychosocial effects of cancer and its treatment
childhood acute lymphoblastic leukemia in remission

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neurotoxicity Syndromes
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders