NCT Number: NCT00085176
Neurobehavioral Complications in Children Who Were Previously Treated With Steroids and Intrathecal Therapy for Acute Lymphoblastic Leukemia
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.
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Notify MeKey information
Conditions
Age range
6 year–16 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Phoenix Children's Hospital, Phoenix, Arizona, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
psychosocial assessment and care
ProcedurePrimary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Children's Oncology Group
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Neurobehavioral Outcomes in Childhood Acute Lymphoblastic Leukemia. A Limited Non-Therapeutic Study
Important dates
- Study start
- 2004
- Primary completion
- 2009
- Study completion
- 2011
- First posted
- Jun 11, 2004
- Registry last updated
- Jan 30, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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