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| ID | Type | Description | Link |
|---|---|---|---|
| COG-ACCL0131 | Other Identifier | Children's Oncology Group | |
| NCI-P01-0198 | |||
| CDR0000069100 | Other Identifier | Clinical Trials.gov |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| management of therapy complications | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with severe intelligence deficit as evidenced by either a verbal or performance IQ below 85 | Length of study |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Previously enrolled on POG-9201 or POG-9605
Eligible for the therapeutic study
Completed therapy by 12/31/2000
No CNS3 at diagnosis
No relapsed disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Previously enrolled on POG-9201 or POG-9605
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| Name | Affiliation | Role |
|---|---|---|
| Patricia K. Duffner, MD | Women & Children's Hospital of Buffalo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
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| Stanford Comprehensive Cancer Center - Stanford |
| Stanford |
| California |
| 94305 |
| United States |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
| Miami Children's Hospital | Miami | Florida | 33155 | United States |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa | Florida | 33607 | United States |
| Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach | Florida | 33407 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 95813 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| CancerCare of Maine at Eastern Maine Medial Center | Bangor | Maine | 04401 | United States |
| Floating Hospital for Children at Tufts - New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| University of Mississippi Cancer Clinic | Jackson | Mississippi | 39216-4505 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | 07601 | United States |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico | 87131-5636 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Baylor University Medical Center - Houston | Houston | Texas | 77030-2399 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78207 | United States |
| Midwest Children's Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Montreal Children's Hospital at McGill University Health Center | Montreal | Quebec | H3H 1P3 | Canada |
| ID | Term |
|---|---|
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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