Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085176
Status:
COMPLETED
Last Update Posted:
2014-01-30
First Post:
2004-06-10
Brief Title:
Neurobehavioral Complications in Children Who Were Previously Treated With Steroids and Intrathecal Therapy for Acute Lymphoblastic Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Neurobehavioral Outcomes in Childhood Acute Lymphoblastic Leukemia A Limited Non-Therapeutic Study
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Cancer therapies may affect the ability of a childs 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| COG-ALTE02C2 | OTHER | None | None |
| CDR0000367480 | OTHER | Clinicaltrialsgov | None |