Neurobehavioral Outcomes in Childhood Acute Lymphoblastic Leukemia. A Limited Non-Therapeutic Stucy
6 Years
16 Years
Both
Leukemia, Long-term Effects Secondary to Cancer Therapy in Children, Neurotoxicity, Psychosocial Effects of Cancer and Its Treatment
Trial Information
Neurobehavioral Outcomes in Childhood Acute Lymphoblastic Leukemia. A Limited Non-Therapeutic Stucy
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Principal Investigator
Nina S. Kadan-Lottick, MD, MSPH
Investigator Role:
Study Chair
Investigator Affiliation:
Yale University
Authority:
United States: Federal Government
Study ID:
CDR0000367480
NCT ID:
NCT00085176
Start Date:
May 2004
Completion Date:
Related Keywords:
- Leukemia
- Long-term Effects Secondary to Cancer Therapy in Children
- Neurotoxicity
- Psychosocial Effects of Cancer and Its Treatment
- long-term effects secondary to cancer therapy in children
- neurotoxicity
- psychosocial effects of cancer and its treatment
- childhood acute lymphoblastic leukemia in remission
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Neurotoxicity Syndromes
Name | Location |
|---|---|
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington, Connecticut 06360-2875 |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| Children's Mercy Hospital | Kansas City, Missouri 64108 |
| Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
| Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
| Phoenix Children's Hospital | Phoenix, Arizona 85016-7710 |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach, California 90801 |
| Yale Cancer Center | New Haven, Connecticut 06520-8028 |
| Blank Children's Hospital | Des Moines, Iowa 50309 |
| NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
| Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
| Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
| Childrens Hospital Los Angeles | Los Angeles, California 90027 |
| Children's Hospital and Research Center Oakland | Oakland, California 94609 |
| Children's Hospital Center for Cancer and Blood Disorders | Aurora, Colorado 80045 |
| Alfred I. duPont Hospital for Children | Wilmington, Delaware 19803 |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor, Michigan 48109-0286 |
| Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
| Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
| Nationwide Children's Hospital | Columbus, Ohio 43205-2696 |
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
| Oregon Health and Science University Cancer Institute | Portland, Oregon 97239-3098 |
