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

Completed

• Conditions: Long-term Effects Secondary to Cancer Therapy in Children; Neurotoxicity

• Registration Number: NCT00028509
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2002-01-04
• Study Start: 2002-07
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2011-07
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-11
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with severe intelligence deficit as evidenced by either a verbal or performance IQ below 85	Length of study

Secondary Outcome Measures

Name	Time	Method
Compare the groups for descriptive purposes	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).

Trial Locations

Locations (26)

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

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