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

This study is ongoing, but not recruiting participants.

First Received: January 4, 2002 Last Updated: May 9, 2009 History of Changes

Sponsors and Collaborators:	Children's Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00028509

Purpose

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	Intervention
Long-Term Effects Secondary to Cancer Therapy in Children Neurotoxicity	Procedure: management of therapy complications

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	162
Study Start Date:	July 2002

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.

Eligibility

Ages Eligible for Study:	1 Year to 9 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028509

Show 26 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Patricia K. Duffner, MD

Women and Children's Hospital of Buffalo

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069100, COG-ACCL0131, NCI-P01-0198
Study First Received:	January 4, 2002
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00028509 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

neurotoxicity
long-term effects secondary to cancer therapy in children

Study placed in the following topic categories:

Neurotoxicity Syndromes
Poisoning
Neoplasm Metastasis
Methotrexate
Disorders of Environmental Origin

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes
Neurotoxicity Syndromes

Nervous System Diseases
Poisoning
Neoplasm Metastasis
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on July 02, 2009