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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00085176 |
RATIONALE: Cancer therapies may affect the ability of a child's brain and central nervous system to function normally. Learning to identify which patients will develop complications may improve the ability of doctors to plan cancer treatment and improve patient quality of life.
PURPOSE: This clinical trial is studying neurobehavioral changes in children who have received steroid therapy or intrathecal therapy for acute lymphoblastic leukemia.
Condition | Intervention |
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Cancer-Related Problem/Condition Leukemia |
Procedure: management of therapy complications Procedure: psychosocial assessment and care |
Study Type: | Interventional |
Study Design: | Supportive Care |
Official Title: | Neurobehavioral Outcomes in Childhood Acute Lymphoblastic Leukemia. A Limited Non-Therapeutic Stucy |
Estimated Enrollment: | 448 |
Study Start Date: | May 2004 |
OBJECTIVES:
OUTLINE: This is a multicenter, cohort study. Patients are assigned to 1 of 2 cohorts (prior treatment per CCG-1922 [prednisone vs dexamethasone] vs prior treatment per CCG-1952 [intrathecal (IT) methotrexate vs IT methotrexate, cytarabine, and hydrocortisone]). Patients in each cohort are stratified according to age at diagnosis, gender, and time since prior treatment termination.
PROJECTED ACCRUAL: A total of 448 patients (224 per cohort) will be accrued for this study within 4 years.
Ages Eligible for Study: | 6 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of standard-risk childhood acute lymphoblastic leukemia (ALL)
Prior enrollment on one of the following Children's Cancer Group (CCG) protocols AND terminated therapy at least 1 year ago:
CCG-1952 (intrathecal methotrexate vs triple intrathecal therapy)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Nina S. Kadan-Lottick, MD, MSPH | Yale University |
Investigator: | Joseph P. Neglia, MD, MPH | Masonic Cancer Center, University of Minnesota |
Study ID Numbers: | CDR0000367480, COG-ALTE02C2 |
Study First Received: | June 10, 2004 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00085176 |
Health Authority: | United States: Federal Government |
long-term effects secondary to cancer therapy in children neurotoxicity psychosocial effects/treatment childhood acute lymphoblastic leukemia in remission |
Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Neurotoxicity Syndromes Neurotoxicity syndromes Neoplasm Metastasis Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |