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

Children's Oncology Group

Status

Completed

Conditions

Psychosocial Effects of Cancer and Its Treatment

Leukemia

Neurotoxicity

Long-term Effects Secondary to Cancer Therapy in Children

Treatments

Procedure: psychosocial assessment and care

Procedure: management of therapy complications

Study type

Observational

Funder types

NETWORK

NIH

Identifiers

NCT00085176

CDR0000367480 (Other Identifier)

ALTE02C2

COG-ALTE02C2 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

286 patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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