Neurobehavioral Complications in Children Who Were Previously Treated With Steroids and Intrathecal Therapy for Acute Lymphoblastic Leukemia

Sponsor

Children's Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00085176

Collaborator

National Cancer Institute (NCI) (NIH)

286

Enrollment

Locations

Duration (Months)

9.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

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.

Study Design

Study Type:

Observational

Actual Enrollment :

286 participants

Time Perspective:

Prospective

Official Title:

Neurobehavioral Outcomes in Childhood Acute Lymphoblastic Leukemia. A Limited Non-Therapeutic Study

Study Start Date :

May 1, 2004

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Jan 1, 2011

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Children's Hospital	Phoenix	Arizona	United States	85016-7710
2	Loma Linda University Cancer Institute at Loma Linda University Medical Center	Loma Linda	California	United States	92354
3	Jonathan Jaques Children's Cancer Center at Miller Children's Hospital	Long Beach	California	United States	90801
4	Childrens Hospital Los Angeles	Los Angeles	California	United States	90027
5	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California	United States	90095-1781
6	Children's Hospital and Research Center Oakland	Oakland	California	United States	94609
7	Children's Hospital Center for Cancer and Blood Disorders	Aurora	Colorado	United States	80045
8	Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center	Farmington	Connecticut	United States	06360-2875
9	Yale Cancer Center	New Haven	Connecticut	United States	06520-8028
10	Alfred I. duPont Hospital for Children	Wilmington	Delaware	United States	19803
11	Children's National Medical Center	Washington	District of Columbia	United States	20010-2970
12	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202-5289
13	Blank Children's Hospital	Des Moines	Iowa	United States	50309
14	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1002
15	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky	United States	40536-0093
16	C.S. Mott Children's Hospital at University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109-0286
17	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503-2560
18	Children's Hospitals and Clinics of Minnesota - Minneapolis	Minneapolis	Minnesota	United States	55404
19	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota	United States	55455
20	Children's Mercy Hospital	Kansas City	Missouri	United States	64108
21	NYU Cancer Institute at New York University Medical Center	New York	New York	United States	10016
22	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
23	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229-3039
24	Nationwide Children's Hospital	Columbus	Ohio	United States	43205-2696
25	Oregon Health and Science University Cancer Institute	Portland	Oregon	United States	97239-3098
26	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104-9786
27	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
28	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838
29	M. D. Anderson Cancer Center at University of Texas	Houston	Texas	United States	77030-4009
30	Primary Children's Medical Center	Salt Lake City	Utah	United States	84113-1100
31	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington	United States	98105