Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia

Completed

Conditions studied: Childhood B Acute Lymphoblastic Leukemia, Childhood T Acute Lymphoblastic Leukemia, Cognitive Side Effects of Cancer Therapy, Long-Term Effects Secondary to Cancer Therapy in Children, Neurotoxicity Syndrome, Psychological Impact of Cancer, Untreated Childhood Acute Lymphoblastic Leukemia

In brief

This clinical trial is looking at brain function in young patients receiving methotrexate for acute lymphoblastic leukemia. Learning about the long-term effects of methotrexate on brain function may help doctors plan cancer treatment.

Key facts

Study ID

NCT00437060

Run by

Children's Oncology Group

People needed

233

Starts

2007-01-01

Last updated by the study team

2017-07-21

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of acute lymphoblastic leukemia
• Enrolled on COG-AALL0434 (Cohort #1 only) or COG-AALL0232 (Cohorts #1 and #2)
• Patients must have received either high-dose methotrexate or escalating-dose methotrexate during interim maintenance.
• No CNS-3 disease
• Patients must enroll within 8-24 months after completion of therapy on COG-AALL0232 and no evidence of relapsed or secondary malignancy
• No known significant neurodevelopmental disability unrelated to cancer diagnosis including, but not limited to, any of the following:
• Down syndrome
• Fragile X mental retardation
• Autism
• Pervasive developmental disability
• Seizure disorder
• Attention-deficit hyperactivity disorder or specific learning disability (e.g., dyslexia) allowed
• No sensory impairment (e.g., pre-existing uncorrectable vision impairment or deafness)
• No cranial radiation therapy

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• Southern California Permanente Medical Group — Downey, California, United States
• Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Children's Hospital Central California — Madera, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Broward Health Medical Center — Fort Lauderdale, Florida, United States
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
• Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Nemours Children's Hospital — Orlando, Florida, United States
• Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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