Neurobehavioral Complications in Children Who Were Previously Treated With Steroids and Intrathecal Therapy for Acute Lymphoblastic Leukemia
- Conditions
- LeukemiaNeurotoxicityPsychosocial Effects of Cancer and Its TreatmentLong-term Effects Secondary to Cancer Therapy in Children
- Registration Number
- NCT00085176
- Lead Sponsor
- Children's Oncology Group
- 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 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 286
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two-sided comparisons of various mean neurobehavioral scores between the two treatment arms within each study 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
Children's Hospital Center for Cancer and Blood Disorders
🇺🇸Aurora, Colorado, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
NYU Cancer Institute at New York University Medical Center
🇺🇸New York, New York, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
🇺🇸Long Beach, California, United States
Children's Hospital and Research Center Oakland
🇺🇸Oakland, California, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Oregon Health and Science University Cancer Institute
🇺🇸Portland, Oregon, United States
Masonic Cancer Center at University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Blank Children's Hospital
🇺🇸Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States