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

Thank you

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 Philadelphia Philadelphia, Pennsylvania  19104
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Farmington, Connecticut  06360-2875
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Mercy Hospital Kansas City, Missouri  64108
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105
Phoenix Children's Hospital Phoenix, Arizona  85016-7710
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Long Beach, California  90801
Yale Cancer Center New Haven, Connecticut  06520-8028
Blank Children's Hospital Des Moines, Iowa  50309
NYU Cancer Institute at New York University Medical Center New York, New York  10016
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Primary Children's Medical Center Salt Lake City, Utah  84113-1100
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Childrens Hospital Los Angeles Los Angeles, California  90027
Children's Hospital and Research Center Oakland Oakland, California  94609
Children's Hospital Center for Cancer and Blood Disorders Aurora, Colorado  80045
Alfred I. duPont Hospital for Children Wilmington, Delaware  19803
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
C.S. Mott Children's Hospital at University of Michigan Medical Center Ann Arbor, Michigan  48109-0286
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota  55404
Nationwide Children's Hospital Columbus, Ohio  43205-2696
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Oregon Health and Science University Cancer Institute Portland, Oregon  97239-3098