Status:
COMPLETED
Neurobehavioral Complications in Children Who Were Previously Treated With Steroids and Intrathecal Therapy for Acute Lymphoblastic Leukemia
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Long-term Effects Secondary to Cancer Therapy in Children
Eligibility:
All Genders
6-16 years
Brief 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 ab...
Detailed Description
OBJECTIVES: * Compare neurobehavioral functioning, specifically memory, attention, executive function, visual-motor integration, and processing speed, in children previously treated with steroids (pr...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT00085176
Start Date
May 1 2004
End Date
January 1 2011
Last Update
January 30 2014
Active Locations (31)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
2
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
3
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States, 90801
4
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027