Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brain Function in Children Previously Treated on Clinical Trials POG-9605 and POG-9201

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00028509
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 13, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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 or disease Intervention/treatment
Long-term Effects Secondary to Cancer Therapy in Children Neurotoxicity Procedure: management of therapy complications

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201
Study Start Date : July 2002
Actual Primary Completion Date : July 2011

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Percentage of patients with severe intelligence deficit as evidenced by either a verbal or performance IQ below 85 [ Time Frame: Length of study ]

Secondary Outcome Measures :
  1. Compare the groups for descriptive purposes [ Time Frame: Length of study ]
    Quantitative scales: IQ (WISC III or WPPSI-R, depending on the age of the child), Wide Range Assessment of Memory and Learning (4 subscales), Conner's Continuous Performance Test (Attention/Concentration), Woodcock Johnson Revised Processing Speed Cluster, NEPSP Tower Tests (Executive Functioning), and VSI (Visual-Motor Integration).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Previously enrolled on POG-9201 or POG-9605
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028509


Locations
Show Show 26 study locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Study Chair: Patricia K. Duffner, MD Women & Children's Hospital of Buffalo
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00028509    
Other Study ID Numbers: ACCL0131
COG-ACCL0131 ( Other Identifier: Children's Oncology Group )
NCI-P01-0198
CDR0000069100 ( Other Identifier: Clinical Trials.gov )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014
Keywords provided by Children's Oncology Group:
neurotoxicity
long-term effects secondary to cancer therapy in children
Additional relevant MeSH terms:
Layout table for MeSH terms
Neurotoxicity Syndromes
Nervous System Diseases
Poisoning
Chemically-Induced Disorders