Neurobehavioral Complications in Children Who Were Previously Treated With Steroids and Intrathecal Therapy for Acute Lymphoblastic Leukemia
NCT ID: NCT00085176
Last Updated: 2014-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
286 participants
OBSERVATIONAL
2004-05-31
2011-01-31
Brief Summary
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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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Detailed Description
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* 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.
Conditions
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Study Design
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PROSPECTIVE
Interventions
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management of therapy complications
psychosocial assessment and care
Eligibility Criteria
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Inclusion Criteria
* 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
6 Years
16 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Nina S. Kadan-Lottick, MD, MSPH
Role: STUDY_CHAIR
Yale University
Joseph P. Neglia, MD, MPH
Role: STUDY_CHAIR
Masonic Cancer Center, University of Minnesota
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Children's Hospital and Research Center Oakland
Oakland, California, United States
Children's Hospital Center for Cancer and Blood Disorders
Aurora, Colorado, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States
Yale Cancer Center
New Haven, Connecticut, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Blank Children's Hospital
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
NYU Cancer Institute at New York University Medical Center
New York, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health and Science University Cancer Institute
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Countries
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References
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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.
Kadan-Lottick NS, Brouwers P, Breiger D, Kaleita T, Dziura J, Liu H, Chen L, Nicoletti M, Stork L, Bostrom B, Neglia JP. A comparison of neurocognitive functioning in children previously randomized to dexamethasone or prednisone in the treatment of childhood acute lymphoblastic leukemia. Blood. 2009 Aug 27;114(9):1746-52. doi: 10.1182/blood-2008-12-186502. Epub 2009 Jun 22.
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.
Other Identifiers
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COG-ALTE02C2
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000367480
Identifier Type: OTHER
Identifier Source: secondary_id
ALTE02C2
Identifier Type: -
Identifier Source: org_study_id
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