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

Tracking Information

First Received Date ^ICMJE

January 4, 2002

Last Updated Date

May 9, 2009

Start Date ^ICMJE

July 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00028509 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Condition ^ICMJE

Long-Term Effects Secondary to Cancer Therapy in Children
Neurotoxicity

Intervention ^ICMJE

Procedure: management of therapy complications

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

162

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Year to 9 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00028509

Responsible Party

Study ID Numbers ^ICMJE

CDR0000069100, COG-ACCL0131, NCI-P01-0198

Study Sponsor ^ICMJE

Children's Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Patricia K. Duffner, MD

Women and Children's Hospital of Buffalo

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP