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

January 29, 2014 updated by: Children's Oncology Group

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
286

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Two-sided comparisons of various mean neurobehavioral scores between the two treatment arms within each study
Time Frame: 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.
length of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Oncology Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Nina S. Kadan-Lottick, MD, MSPH, Yale University
  • Study Chair: Joseph P. Neglia, MD, MPH, Masonic Cancer Center, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALTE02C2
  • COG-ALTE02C2 (Other Identifier: Children's Oncology Group)
  • CDR0000367480 (Other Identifier: Clinicaltrials.gov)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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