This is a multicenter, randomized, controlled, open-label study. Patients meeting inclusion/exclusion criteria will be randomized (1:1) to receive two cycles of MAb-3F8 plus GM-CSF or RA plus GM-CSF. Patients who do not respond to their assigned treatment after two cycles may cross-over to receive the alternate treatment. Disease response and safety will be assessed in all patients after cycle 2 and after cycle 4.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Phoenix Children's Hospital
Phoenix, Arizona, United States
Rady Children's Hospital of San Diego
San Diego, California, United States
To compare the proportion of patients achieving a complete bone marrow response measured by an absence of histological evidence of bone marrow disease and by MIBG scan after two cycles of treatment.
Time frame: two years
A comparison in treatment arms for disease response as measured by CT/MRI scan and urine catecholamines, MIBG extent of disease scores, disease response in cross-over patients.
Time frame: two years
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Georgetown Medical Center
Washington D.C., District of Columbia, United States
All Children's Hospital in Florida
St. Petersburg, Florida, United States
LSU Health Sciences Center; Children's Hospital
New Orleans, Louisiana, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Nationwide Childrens Hospital
Columbus, Ohio, United States
University of Oklahoma Cancer Center
Oklahoma City, Oklahoma, United States
...and 5 more locations