Spots Global Cancer Trial Database for A Study of MAb-3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Versus 13-cis-Retinoic Acid (RA) Plus GM-CSF in Primary Refractory Neuroblastoma Patients
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Trial Identification
Brief Title: A Study of MAb-3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Versus 13-cis-Retinoic Acid (RA) Plus GM-CSF in Primary Refractory Neuroblastoma Patients
Official Title: A Randomized Study of Monoclonal Antibody 3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Compared to 13-cis-Retinoic Acid Plus GM-CSF in High Risk Stage 4, Primary Refractory Neuroblastoma Patients
Study ID: NCT00969722
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Months
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Phoenix Children's Hospital, Phoenix, Arizona, United States
Rady Children's Hospital of San Diego, San Diego, California, United States
Georgetown Medical Center, Washington, 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, 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
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
US Oncology, Dallas, Texas, United States
The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
University of Utah Medical Center, Salt Lake City, Utah, United States
Vermont Cancer Center, Burlington, Vermont, United States
Contact Details
Name: Peter E. Zage, M.D.
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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