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


N/A
1 Year
9 Years
Not Enrolling
Both
Long-term Effects Secondary to Cancer Therapy in Children, Neurotoxicity

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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 InstituteBuffalo, New York  14263
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Hurley Medical CenterFlint, Michigan  48503
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Rush University Medical CenterChicago, Illinois  60612-3824
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Miami Children's HospitalMiami, Florida  33155-4069
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
CancerCare of Maine at Eastern Maine Medial CenterBangor, Maine  04401
Floating Hospital for Children at Tufts - New England Medical CenterBoston, Massachusetts  02111
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Stanford Comprehensive Cancer Center - StanfordStanford, California  94305