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A Study of Neurocognitive Function in Children Treated for ALL

1 Year
17 Years
Open (Enrolling)
Cognitive/Functional Effects, Leukemia, Long-term Effects Secondary to Cancer Therapy in Children, Neurotoxicity, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

A Study of Neurocognitive Function in Children Treated for ALL


- Determine the neuropsychological function in children with acute lymphoblastic leukemia
treated with either high-dose methotrexate or escalating-dose methotrexate in the
absence of cranial radiation and nelarabine.

- Identify host polymorphisms that predict an increased risk of neurocognitive
dysfunction or acute neurotoxicity in these patients.

- Correlate neuropsychological outcome measures and the occurrence of acute neurotoxicity
with host polymorphisms in these patients.

- Measure concentrations of 5-methyltetrahydrofolate, homocysteine, Ado,
S-adenosylmethionine, S-adenosylhomocysteine, and other potentially relevant compounds
in serum and cerebrospinal fluid during interim maintenance therapy with low- or
high-dose methotrexate regimens, respectively, and correlate these endpoints with the
occurrence of acute neurologic toxicity and long-term neurocognitive dysfunction in
these patients.

- Determine whether or not diffusion tensor imaging will identify areas of selective
vulnerability in CNS and provide an imaging modality that predicts and/or correlates
with neuropsychological outcome.

OUTLINE: This is a prospective, cohort, multicenter study.

Patients complete neurocognitive tests to assess thinking, memory, attention, and
concentration. The baseline test is administered during the consolidation phase of
chemotherapy and further tests are done at 1 year from baseline and 1 year after* the
completion of study therapy.

Patients undergo blood and cerebrospinal fluid collection periodically for biomarker,
genotypic polymorphisms, and pharmacokinetic analysis.

Patients undergo MRI diffusion-tensor imaging to correlate imaging with neuropsychological

NOTE: * Within 8 months to 24 months after the completion of study therapy for patients on

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.

Inclusion Criteria


- Diagnosis of acute lymphoblastic leukemia

- Enrolled on COG-AALL0434 or COG-AALL0232

- Patients must have received either high-dose methotrexate or escalating-dose
methotrexate during interim maintenance.

- No CNS-3 disease

- Patients must enroll within 8-24 months after completion of therapy on COG-AALL0232
and no evidence of relapsed or secondary malignancy


- No known significant neurodevelopmental disability unrelated to cancer diagnosis
including, but not limited to, any of the following:

- Down syndrome

- Fragile X mental retardation

- Autism

- Pervasive developmental disability

- Seizure disorder

- Attention-deficit hyperactivity disorder or specific learning disability (e.g.,
dyslexia) allowed

- No sensory impairment (e.g., pre-existing uncorrectable vision impairment or


- See Disease Characteristics

- No cranial radiation therapy

Type of Study:


Study Design:


Outcome Measure:

Full Scale IQ as assessed by standardized age-appropriate test of developmental or neurocognitive function

Principal Investigator

Naomi J. Winick, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center



Study ID:




Start Date:

January 2007

Completion Date:

Related Keywords:

  • Cognitive/Functional Effects
  • Leukemia
  • Long-term Effects Secondary to Cancer Therapy in Children
  • Neurotoxicity
  • Psychosocial Effects of Cancer and Its Treatment
  • neurotoxicity
  • psychosocial effects of cancer and its treatment
  • cognitive/functional effects
  • long-term effects secondary to cancer therapy in children
  • T-cell childhood acute lymphoblastic leukemia
  • untreated childhood acute lymphoblastic leukemia
  • B-cell childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Neurotoxicity Syndromes



Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Hurley Medical CenterFlint, Michigan  48503
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
All Children's HospitalSt. Petersburg, Florida  33701
Driscoll Children's HospitalCorpus Christi, Texas  78466
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Southern California Permanente Medical GroupDowney, California  90242
Children's Hospital Central CaliforniaMadera, California  93638-8762
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Covenant Children's HospitalLubbock, Texas  79410
Midwest Children's Cancer Center at Children's Hospital of WisconsinMilwaukee, Wisconsin  53226
Winthrop University HospitalMineola, New York  11501
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
Broward General Medical Center Cancer CenterFt. Lauderdale, Florida  33316
Nemours Children's Clinic - OrlandoOrlando, Florida  32806
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Blank Children's HospitalDes Moines, Iowa  50309
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
Floating Hospital for Children at Tufts - New England Medical CenterBoston, Massachusetts  02111
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida  33021
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Childrens Hospital Los AngelesLos Angeles, California  90027
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo Alto, California  95798
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Children's Hospital Center for Cancer and Blood DisordersAurora, Colorado  80045
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston CampusAtlanta, Georgia  30322
Keyser Family Cancer Center at Advocate Hope Children's HospitalOak Lawn, Illinois  60453
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
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
Legacy Emanuel Hospital and Health Center and Children's HospitalPortland, Oregon  97227
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Madigan Army Medical Center - TacomaTacoma, Washington  98431
Mary Bridge Children's Hospital and Health Center - TacomaTacoma, Washington  98405
Massachusetts General HospitalBoston, Massachusetts  02114-2617
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Greenville Hospital Cancer CenterGreenville, South Carolina  29605
T.C. Thompson Children's HospitalChattanooga, Tennessee  37403
Connecticut Children's Medical CenterHartford, Connecticut  06106
Nemours Children's Clinic - PensacolaPensacola, Florida  32504
Helen DeVos Children's Hospital at Spectrum HealthGrand Rapids, Michigan  49503