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Study of Clinical and Neurological Evidence of Methotrexate Leukoencephalopathy in Children Previously Treated on Protocols POG-9605 and POG-9201

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Natural history/Epidemiology Closed 1 to 9 at diagnosis NCI COG-ACCL0131
NCI-P01-0198, NCT00028509, ACCL0131

Objectives

Compare the incidence of neuropsychological abnormalities and leukoencephalopathy in children previously treated with methotrexate on protocols POG-9605 versus POG-9201.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

See Disease Characteristics

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

Expected Enrollment

162

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.

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.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Patricia Duffner, MD, Protocol chair
Ph: 716-881-8908
Email: pduffner@kaleidahealth.org

Related Information

PDQ® clinical trial POG-9201
PDQ® clinical trial POG-9605

Registry Information

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

Trial Start Date		2002-07-29

Registered in ClinicalTrials.gov		NCT00028509

Date Submitted to PDQ		2001-10-18

Information Last Verified		2007-06-26

NCI Grant/Contract Number		CA13539, CA30969, CA37400

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.