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

NCT00085176 | Completed DMC

• 3 other identifiers: ALTE02C2COG-ALTE02C2CDR0000367480
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 31

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.

Conditions

Leukemia; Long-term Effects Secondary to Cancer Therapy in Children; Neurotoxicity; Psychosocial Effects of Cancer and Its Treatment

Keywords

long-term effects secondary to cancer therapy in children; neurotoxicity; psychosocial effects of cancer and its treatment; childhood acute lymphoblastic leukemia in remission

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

management of therapy complications PROCEDURE

psychosocial assessment and care PROCEDURE

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children previously randomized to (1) dexamethasone instead of prednisone on COG 1922 and (2) intrathecal methotrexate, cytarabine, and hydrocortisone (triple therapy) instead of intrathecal methotrexate alone on COG 1952

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (31)

Phoenix Children's Hospital

Phoenix, Arizona, 85016-7710, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

Long Beach, California, 90801, United States

Location

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Children's Hospital and Research Center Oakland

Oakland, California, 94609, United States

Location

Children's Hospital Center for Cancer and Blood Disorders

Aurora, Colorado, 80045, United States

Location

Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

Farmington, Connecticut, 06360-2875, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

C.S. Mott Children's Hospital at University of Michigan Medical Center

Ann Arbor, Michigan, 48109-0286, United States

Location

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, 49503-2560, United States

Location

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205-2696, United States

Location

Oregon Health and Science University Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-9786, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113-1100, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

Related Publications (5)

• 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-9546, 2012.

  RESULT

• 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 childhood acute lymphoblastic leukemia. Blood. 2009 Aug 27;114(9):1746-52. doi: 10.1182/blood-2008-12-186502. Epub 2009 Jun 22.

  PMID: 19546477 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Leukemia; Neurotoxicity Syndromes

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nina S. Kadan-Lottick, MD, MSPH

  Yale University

  STUDY CHAIR

• Joseph P. Neglia, MD, MPH

  Masonic Cancer Center, University of Minnesota

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: May 1, 2004
• Primary Completion: September 1, 2009
• Study Completion: January 1, 2011
• Last Updated: January 30, 2014

Record last verified: 2014-01

Locations

US (31)