Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201
1 Year
9 Years
Both
Long-term Effects Secondary to Cancer Therapy in Children, Neurotoxicity
Trial Information
Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201
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.
Inclusion 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
Type of Study:
Observational
Study Design:
N/A
Principal Investigator
Patricia K. Duffner, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Women & Children's Hospital of Buffalo
Authority:
United States: Federal Government
Study ID:
CDR0000069100
NCT ID:
NCT00028509
Start Date:
July 2002
Completion Date:
Related Keywords:
- Long-term Effects Secondary to Cancer Therapy in Children
- Neurotoxicity
- neurotoxicity
- long-term effects secondary to cancer therapy in children
- Neurotoxicity Syndromes
- Leukoencephalopathies
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Hurley Medical Center | Flint, Michigan 48503 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Rush University Medical Center | Chicago, Illinois 60612-3824 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Miami Children's Hospital | Miami, Florida 33155-4069 |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa, Florida 33607 |
| Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach, Florida 33407 |
| CancerCare of Maine at Eastern Maine Medial Center | Bangor, Maine 04401 |
| Floating Hospital for Children at Tufts - New England Medical Center | Boston, Massachusetts 02111 |
| Hackensack University Medical Center Cancer Center | Hackensack, New Jersey 07601 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
| University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
| Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
| Stanford Comprehensive Cancer Center - Stanford | Stanford, California 94305 |
