Neurobehavioral Complications in Children Who Were Previously Treated With Steroids and Intrathecal Therapy for Acute Lymphoblastic Leukemia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Leukemia Long-term Effects Secondary to Cancer Therapy in Children Neurotoxicity Psychosocial Effects of Cancer and Its Treatment |
Procedure: management of therapy complications Procedure: psychosocial assessment and care |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Supportive Care |
| Official Title: | Neurobehavioral Outcomes in Childhood Acute Lymphoblastic Leukemia. A Limited Non-Therapeutic Stucy |
| Estimated Enrollment: | 448 |
| Study Start Date: | May 2004 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 6 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 31 Study Locations| Study Chair: | Nina S. Kadan-Lottick, MD, MSPH | Yale University |
| Investigator: | Joseph P. Neglia, MD, MPH | Masonic Cancer Center, University of Minnesota |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00085176 History of Changes |
| Other Study ID Numbers: | CDR0000367480, COG-ALTE02C2 |
| Study First Received: | June 10, 2004 |
| Last Updated: | June 14, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
long-term effects secondary to cancer therapy in children neurotoxicity psychosocial effects of cancer and its treatment childhood acute lymphoblastic leukemia in remission |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neurotoxicity Syndromes Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Nervous System Diseases Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on June 13, 2013