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


N/A
6 Years
16 Years
Not Enrolling
Both
Leukemia, Long-term Effects Secondary to Cancer Therapy in Children, Neurotoxicity, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

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


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.

Inclusion 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

- Not specified

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- See Disease Characteristics

Radiotherapy

- See Disease Characteristics

Surgery

- See Disease Characteristics

Other

- Concurrent stimulants allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Nina S. Kadan-Lottick, MD, MSPH

Investigator Role:

Study Chair

Investigator Affiliation:

Yale University

Authority:

United States: Federal Government

Study ID:

CDR0000367480

NCT ID:

NCT00085176

Start Date:

May 2004

Completion Date:

Related Keywords:

  • Leukemia
  • Long-term Effects Secondary to Cancer Therapy in Children
  • Neurotoxicity
  • Psychosocial Effects of Cancer and Its Treatment
  • long-term effects secondary to cancer therapy in children
  • neurotoxicity
  • psychosocial effects of cancer and its treatment
  • childhood acute lymphoblastic leukemia in remission
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Neurotoxicity Syndromes

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health CenterFarmington, Connecticut  06360-2875
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Blank Children's HospitalDes Moines, Iowa  50309
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Childrens Hospital Los AngelesLos Angeles, California  90027
Children's Hospital and Research Center OaklandOakland, California  94609
Children's Hospital Center for Cancer and Blood DisordersAurora, Colorado  80045
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
C.S. Mott Children's Hospital at University of Michigan Medical CenterAnn Arbor, Michigan  48109-0286
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
Nationwide Children's HospitalColumbus, Ohio  43205-2696
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Oregon Health and Science University Cancer InstitutePortland, Oregon  97239-3098