Neurobehavioral Complications in Children Who Were Previously Treated With Steroids and Intrathec… (NCT00085176) | Clinical Trial Compass
CompletedNot Applicable
Neurobehavioral Complications in Children Who Were Previously Treated With Steroids and Intrathecal Therapy for Acute Lymphoblastic Leukemia
United States286 participantsStarted 2004-05
Plain-language 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.
Who can participate
Age range6 Years – 16 Years
SexALL
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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
What they're measuring
1
Two-sided comparisons of various mean neurobehavioral scores between the two treatment arms within each study