Brain Function in Children Previously Treated on Clinical Trials POG-9605 and POG-9201
NCT ID: NCT00028509
Last Updated: 2014-02-13
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
66 participants
OBSERVATIONAL
2002-07-31
Brief Summary
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PURPOSE: Clinical trial to compare brain function of children who have been previously treated with methotrexate.
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Detailed Description
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* Compare the incidence of neuropsychological abnormalities and leukoencephalopathy in children previously treated with methotrexate on protocols POG-9605 versus POG-9201.
OUTLINE: This is a multicenter study.
More than 3 years after completion of therapy, patients undergo 9 different tests to assess intelligence, memory, learning, attention, concentration, processing of information, functioning, and visual-motor integration. Patients also undergo MRI of the head.
PROJECTED ACCRUAL: A total of 30-54 patients previously treated on protocol POG-9201 will be accrued for this study. A total of 60-108 patients previously treated on protocol POG-9605 will be accrued for this study.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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management of therapy complications
Eligibility Criteria
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Inclusion Criteria
* No CNS3 at diagnosis
* No relapsed disease
PATIENT CHARACTERISTICS:
Age:
* 1 to 9 at diagnosis
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No Down syndrome
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* See Disease Characteristics
1 Year
9 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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Patricia K. Duffner, MD
Role: STUDY_CHAIR
Women & Children's Hospital of Buffalo
Locations
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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Stanford Comprehensive Cancer Center - Stanford
Stanford, California, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Rush University Medical Center
Chicago, Illinois, United States
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States
Floating Hospital for Children at Tufts - New England Medical Center
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Baylor University Medical Center - Houston
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada
Countries
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Other Identifiers
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COG-ACCL0131
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-P01-0198
Identifier Type: -
Identifier Source: secondary_id
CDR0000069100
Identifier Type: OTHER
Identifier Source: secondary_id
ACCL0131
Identifier Type: -
Identifier Source: org_study_id
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