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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 Philadelphia Philadelphia, Pennsylvania  19104
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Hurley Medical Center Flint, Michigan  48503
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Children's Hospital of Orange County Orange, California  92668
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105
Nemours Children's Clinic Jacksonville, Florida  32207
Miami Children's Hospital Miami, Florida  33155-4069
All Children's Hospital St. Petersburg, Florida  33701
Driscoll Children's Hospital Corpus Christi, Texas  78466
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
Southern California Permanente Medical Group Downey, California  90242
Children's Hospital Central California Madera, California  93638-8762
East Tennessee Children's Hospital Knoxville, Tennessee  37901
Covenant Children's Hospital Lubbock, Texas  79410
Midwest Children's Cancer Center at Children's Hospital of Wisconsin Milwaukee, Wisconsin  53226
Winthrop University Hospital Mineola, New York  11501
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Long Beach, California  90801
Yale Cancer Center New Haven, Connecticut  06520-8028
Lee Cancer Care of Lee Memorial Health System Fort Myers, Florida  33901
Broward General Medical Center Cancer Center Ft. Lauderdale, Florida  33316
Nemours Children's Clinic - Orlando Orlando, Florida  32806
St. Joseph's Cancer Institute at St. Joseph's Hospital Tampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical Center West Palm Beach, Florida  33407
St. Vincent Indianapolis Hospital Indianapolis, Indiana  46260
Blank Children's Hospital Des Moines, Iowa  50309
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore, Maryland  21215
Floating Hospital for Children at Tufts - New England Medical Center Boston, Massachusetts  02111
Breslin Cancer Center at Ingham Regional Medical Center Lansing, Michigan  48910
Hackensack University Medical Center Cancer Center Hackensack, New Jersey  07601
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Rainbow Babies and Children's Hospital Cleveland, Ohio  44106-5000
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Baylor University Medical Center - Houston Houston, Texas  77030-2399
Methodist Children's Hospital of South Texas San Antonio, Texas  78229-3993
Primary Children's Medical Center Salt Lake City, Utah  84113-1100
Providence Cancer Center at Sacred Heart Medical Center Spokane, Washington  99220-2555
Mary Babb Randolph Cancer Center at West Virginia University Hospitals Morgantown, West Virginia  26506
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Memorial Cancer Institute at Memorial Regional Hospital Hollywood, Florida  33021
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Los Angeles, California  90048-1865
Childrens Hospital Los Angeles Los Angeles, California  90027
Lucile Packard Children's Hospital at Stanford University Medical Center Palo Alto, California  95798
Rady Children's Hospital - San Diego San Diego, California  92123-4282
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Children's Hospital Center for Cancer and Blood Disorders Aurora, Colorado  80045
Alfred I. duPont Hospital for Children Wilmington, Delaware  19803
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus Atlanta, Georgia  30322
Keyser Family Cancer Center at Advocate Hope Children's Hospital Oak Lawn, Illinois  60453
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
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota  55404
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Nationwide Children's Hospital Columbus, Ohio  43205-2696
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Knight Cancer Institute at Oregon Health and Science University Portland, Oregon  97239-3098
Legacy Emanuel Hospital and Health Center and Children's Hospital Portland, Oregon  97227
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania  15213
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Madigan Army Medical Center - Tacoma Tacoma, Washington  98431
Mary Bridge Children's Hospital and Health Center - Tacoma Tacoma, Washington  98405
Massachusetts General Hospital Boston, Massachusetts  02114-2617
UAB Comprehensive Cancer Center Birmingham, Alabama  35294
University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136
Greenville Hospital Cancer Center Greenville, South Carolina  29605
T.C. Thompson Children's Hospital Chattanooga, Tennessee  37403
Connecticut Children's Medical Center Hartford, Connecticut  06106
Nemours Children's Clinic - Pensacola Pensacola, Florida  32504
Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan  49503