Spots Global Cancer Trial Database for Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia
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Trial Identification
Brief Title: Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia
Official Title: A Study of Neurocognitive Function in Children Treated for ALL
Study ID: NCT00437060
Study Description
Brief Summary: This clinical trial is looking at brain function in young patients receiving methotrexate for acute lymphoblastic leukemia. Learning about the long-term effects of methotrexate on brain function may help doctors plan cancer treatment.
Detailed Description: OBJECTIVES: 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.
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint 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
Contact Details
Name: Naomi Winick
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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