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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00085176
• Other study ID #: ALTE02C2
• Secondary ID: COG-ALTE02C2CDR0
• Status: Completed
• Phase: N/A
• First received: June 10, 2004
• Last updated: January 29, 2014
• Start date: May 2004
• Est. completion date: January 2011

Study information

• Verified date: January 2014
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: January 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Long-term Effects Secondary to Cancer Therapy in Children
• Neurotoxicity
• Neurotoxicity Syndromes
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Procedure:
• management of therapy complications

• psychosocial assessment and care

Locations

Country	Name	City	State
United States	C.S. Mott Children's Hospital at University of Michigan Medical Center	Ann Arbor	Michigan
United States	Children's Hospital Center for Cancer and Blood Disorders	Aurora	Colorado
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Blank Children's Hospital	Des Moines	Iowa
United States	Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center	Farmington	Connecticut
United States	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky
United States	Loma Linda University Cancer Institute at Loma Linda University Medical Center	Loma Linda	California
United States	Jonathan Jaques Children's Cancer Center at Miller Children's Hospital	Long Beach	California
United States	Childrens Hospital Los Angeles	Los Angeles	California
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California
United States	Children's Hospitals and Clinics of Minnesota - Minneapolis	Minneapolis	Minnesota
United States	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Yale Cancer Center	New Haven	Connecticut
United States	NYU Cancer Institute at New York University Medical Center	New York	New York
United States	Children's Hospital and Research Center Oakland	Oakland	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University Cancer Institute	Portland	Oregon
United States	Primary Children's Medical Center	Salt Lake City	Utah
United States	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington
United States	Children's National Medical Center	Washington	District of Columbia
United States	Alfred I. duPont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Breiger D, Kaleita TA, Kadan-Lottick NS, et al.: Behavioral social adjustment in survivors of childhood acute lymphoblastic leukemia (ALL) treated without cranial radiation. [Abstract] Pediatr Blood Cancer 46 (6): A-3505.43, 690, 2006.

Kadan-Lottick NS, Brouwers P, Breiger D, Kaleita T, Dziura J, Liu H, Chen L, Nicoletti M, Stork L, Bostrom B, Neglia JP. A comparison of neurocognitive functioning in children previously randomized to dexamethasone or prednisone in the treatment of childh — View Citation

Kadan-Lottick NS, Brouwers P, Kaleita TA, et al.: Preliminary findings of neurobehavioral outcomes in survivors of childhood acute lymphoblastic leukemia (ALL) treated without cranial radiation. [Abstract] Pediatr Blood Cancer 46 (6): A-3505.45, 691, 2006

Kadan-Lottick NS, Stork LC, Bostrom BC, et al.: Increased prevalence of overweight status in survivors of acute lymphoblastic leukemia (ALL) treated without cranial radiation . [Abstract] Pediatr Blood Cancer 46 (6): A-3505.44, 690, 2006.

Lindemulder SJ, Stork LC, Bostrom BC, et al.: Trends in body mass index (BMI) during and after treatment for standard risk (SR) acute lymphoblastic leukemia (ALL): A report from the Children's Oncology Group (COG). [Abstract] J Clin Oncol 30 (Suppl 15): A

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two-sided comparisons of various mean neurobehavioral scores between the two treatment arms within each 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.	length of study	No