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

Neurotoxicity Clinical Trial

Official title:

Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00028509
• Other study ID #: ACCL0131
• Secondary ID: COG-ACCL0131NCI-
• Status: Completed
• Phase: N/A
• First received: January 4, 2002
• Last updated: February 11, 2014
• Start date: July 2002

Study information

• Verified date: February 2014
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 9 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Long-term Effects Secondary to Cancer Therapy in Children
• Neurotoxicity
• Neurotoxicity Syndromes

Intervention

Procedure:
• management of therapy complications

Locations

Country	Name	City	State
Canada	Montreal Children's Hospital at McGill University Health Center	Montreal	Quebec
United States	University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico
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	Roswell Park Cancer Institute	Buffalo	New York
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
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	Hackensack University Medical Center Cancer Center	Hackensack	New Jersey
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Baylor University Medical Center - Houston	Houston	Texas
United States	University of Mississippi Cancer Clinic	Jackson	Mississippi
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Miami Children's Hospital	Miami	Florida
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida
United States	Midwest Children's Cancer Center	Milwaukee	Wisconsin
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Siteman Cancer Center at Barnes-Jewish Hospital	St. Louis	Missouri
United States	Stanford Comprehensive Cancer Center - Stanford	Stanford	California
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	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with severe intelligence deficit as evidenced by either a verbal or performance IQ below 85		Length of study	No
Secondary	Compare the groups for descriptive purposes	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).	Length of study	No