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Brain Function in Children Previously Treated on Clinical Trials POG-9605 and POG-9201
This study is ongoing, but not recruiting participants.
First Received: January 4, 2002   Last Updated: May 9, 2009   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028509
  Purpose

RATIONALE: Assessing the effects of methotrexate on brain function in children may improve the ability to plan treatment and decrease side effects.

PURPOSE: Clinical trial to compare brain function of children who have been previously treated with methotrexate.


Condition Intervention
Long-Term Effects Secondary to Cancer Therapy in Children
Neurotoxicity
Procedure: management of therapy complications

Study Type: Observational
Official Title: Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 162
Study Start Date: July 2002
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   1 Year to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Previously enrolled on POG-9201 or POG-9605

    • Good prognosis by NCI risk (9201 and 9605 stratum 1)
  • Eligible for the therapeutic study
  • Completed therapy by 12/31/2000
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028509

  Hide Study Locations
Locations
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Stanford Comprehensive Cancer Center - Stanford
Stanford, California, United States, 94305
United States, Florida
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States, 33607
Miami Children's Hospital
Miami, Florida, United States, 33155
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 95813
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maine
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States, 04401
United States, Massachusetts
Floating Hospital for Children at Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48503
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030-2399
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
United States, Wisconsin
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Canada, Quebec
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada, H3H 1P3
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Patricia K. Duffner, MD Women and Children's Hospital of Buffalo
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069100, COG-ACCL0131, NCI-P01-0198
Study First Received: January 4, 2002
Last Updated: May 9, 2009
ClinicalTrials.gov Identifier: NCT00028509     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
neurotoxicity
long-term effects secondary to cancer therapy in children

Additional relevant MeSH terms:
Neoplasms
Neoplastic Processes
Pathologic Processes
Neurotoxicity Syndromes
Nervous System Diseases
Poisoning
Neoplasm Metastasis
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on November 25, 2009