Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia
NCT ID: NCT00437060
Last Updated: 2017-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
233 participants
OBSERVATIONAL
2007-01-31
Brief Summary
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Detailed Description
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I. 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.
II. Identify host polymorphisms that predict an increased risk of neurocognitive dysfunction or acute neurotoxicity in these patients.
III. Correlate neuropsychological outcome measures and the occurrence of acute neurotoxicity with host polymorphisms in these patients.
IV. 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.
V. 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 outcomes.
NOTE: \* Within 8 months to 24 months after the completion of study therapy for patients on AALL0232.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ancillary/Correlative (neurocognitive assessment, biomarkers))
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 outcomes.
Cognitive Assessment
Ancillary studies
Diffusion Tensor Imaging
Correlative studies
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Psychosocial Assessment and Care
Ancillary studies
Interventions
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Cognitive Assessment
Ancillary studies
Diffusion Tensor Imaging
Correlative studies
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Psychosocial Assessment and Care
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Enrolled on COG-AALL0434 (Cohort #1 only) or COG-AALL0232 (Cohorts #1 and #2)
* 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 deafness)
* No cranial radiation therapy
1 Year
17 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Naomi Winick
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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Children's Hospital of Alabama
Birmingham, Alabama, United States
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Southern California Permanente Medical Group
Downey, California, United States
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Children's Hospital Central California
Madera, California, United States
Children's Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
UCSF Medical Center-Parnassus
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Nemours Children's Hospital
Orlando, Florida, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States
Saint Mary's Hospital
West Palm Beach, Florida, United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
Blank Children's Hospital
Des Moines, Iowa, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Michigan State University Clinical Center
East Lansing, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Winthrop University Hospital
Mineola, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
New York Medical College
Valhalla, New York, United States
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States
Legacy Emanuel Children's Hospital
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States
Greenville Cancer Treatment Center
Greenville, South Carolina, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
T C Thompson Children's Hospital
Chattanooga, Tennessee, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Covenant Children's Hospital
Lubbock, Texas, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Saint Vincent Hospital
Green Bay, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Royal Children's Hospital-Brisbane
Herston, Queensland, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
University of Alberta Hospital
Edmonton, Alberta, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Starship Children's Hospital
Grafton, Auckland, New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Countries
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Other Identifiers
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NCI-2009-00315
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000528920
Identifier Type: -
Identifier Source: secondary_id
AALL06N1
Identifier Type: OTHER
Identifier Source: secondary_id
AALL06N1
Identifier Type: OTHER
Identifier Source: secondary_id
AALL06N1
Identifier Type: -
Identifier Source: org_study_id
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