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

Thank you

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