Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma
Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Regional Neuroblastoma

About this trial
This is an interventional treatment trial for Localized Resectable Neuroblastoma
Eligibility Criteria
Inclusion Criteria: Newly diagnosed neuroblastoma (NBL) or ganglioneuroblastoma with tumor-associated opsoclonus-myoclonus-ataxia syndrome (OMA) Patients with NBL diagnosed within 6 months of OMA diagnosis AND patients with OMA diagnosed within 6 months of NBL diagnosis are eligible Must enroll on study within 4 weeks of diagnosis Presence of opsoclonus, myoclonus, and/or ataxia associated with neuroblastoma considered eligible Currently enrolled on COG neuroblastoma protocols: COG-ANBL00B1 or its successor Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows: ≤ 0.4 mg/dL (for patients 1 to 5 months of age) ≤ 0.5 mg/dL (for patients 6 to 11 months of age) ≤ 0.6 mg/dL (for patients 1 year of age) ≤ 0.8 mg/dL (for patients 2 to 5 years of age) ≤ 1.0 mg/dL (for patients 6 to 9 years of age) ≤ 1.2 mg/dL (for patients 10 to 12 years of age) ≤ 1.4 mg/dL (for female patients ≥ 13 years of age) ≤ 1.5 mg/dL (for male patients 13 to 15 years of age) ≤ 1.6 mg/dL (for male patients ≥ 16 years of age) No prior IV gamma globulin therapy No prior chemotherapy Concurrent chemotherapy allowed No prior prednisone or corticotropin Patients who have received ≤ 14 days of steroids are eligible Concurrent surgery allowed
Sites / Locations
- Children's Hospital of Alabama
- University of Alabama at Birmingham Cancer Center
- Banner University Medical Center - Tucson
- University of Arkansas for Medical Sciences
- Loma Linda University Medical Center
- Miller Children's and Women's Hospital Long Beach
- Cedars Sinai Medical Center
- Valley Children's Hospital
- Kaiser Permanente-Oakland
- Lucile Packard Children's Hospital Stanford University
- Rady Children's Hospital - San Diego
- UCSF Medical Center-Mount Zion
- UCSF Medical Center-Parnassus
- Harbor-University of California at Los Angeles Medical Center
- Children's Hospital Colorado
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
- Connecticut Children's Medical Center
- Alfred I duPont Hospital for Children
- MedStar Georgetown University Hospital
- Children's National Medical Center
- Broward Health Medical Center
- Lee Memorial Health System
- Nemours Children's Clinic-Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Nemours Children's Clinic - Orlando
- Nemours Children's Clinic - Pensacola
- Sacred Heart Hospital
- Johns Hopkins All Children's Hospital
- Saint Joseph's Hospital/Children's Hospital-Tampa
- Saint Mary's Hospital
- Children's Healthcare of Atlanta - Egleston
- Emory University Hospital/Winship Cancer Institute
- Saint Luke's Cancer Institute - Boise
- Lurie Children's Hospital-Chicago
- University of Chicago Comprehensive Cancer Center
- Saint Jude Midwest Affiliate
- Indiana University/Melvin and Bren Simon Cancer Center
- Riley Hospital for Children
- University of Kentucky/Markey Cancer Center
- Norton Children's Hospital
- Tulane University Health Sciences Center
- Sinai Hospital of Baltimore
- Tufts Children's Hospital
- Massachusetts General Hospital Cancer Center
- Dana-Farber Cancer Institute
- Wayne State University/Karmanos Cancer Institute
- Ascension Saint John Hospital
- Michigan State University Clinical Center
- Hurley Medical Center
- Helen DeVos Children's Hospital at Spectrum Health
- Spectrum Health at Butterworth Campus
- University of Mississippi Medical Center
- Children's Mercy Hospitals and Clinics
- Nevada Cancer Research Foundation NCORP
- Hackensack University Medical Center
- Morristown Medical Center
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
- Newark Beth Israel Medical Center
- Saint Joseph's Regional Medical Center
- Overlook Hospital
- Albany Medical Center
- Roswell Park Cancer Institute
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- State University of New York Upstate Medical University
- New York Medical College
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Duke University Medical Center
- Wake Forest University Health Sciences
- Children's Hospital Medical Center of Akron
- Nationwide Children's Hospital
- Dayton Children's Hospital
- University of Oklahoma Health Sciences Center
- Legacy Emanuel Children's Hospital
- Legacy Emanuel Hospital and Health Center
- Penn State Milton S Hershey Medical Center
- Penn State Children's Hospital
- Children's Hospital of Philadelphia
- Saint Christopher's Hospital for Children
- Children's Hospital of Pittsburgh of UPMC
- Medical University of South Carolina
- Prisma Health Richland Hospital
- BI-LO Charities Children's Cancer Center
- Greenville Cancer Treatment Center
- Sanford USD Medical Center - Sioux Falls
- East Tennessee Childrens Hospital
- Texas Tech University Health Sciences Center-Amarillo
- Driscoll Children's Hospital
- Medical City Dallas Hospital
- Cook Children's Medical Center
- Methodist Children's Hospital of South Texas
- University of Texas Health Science Center at San Antonio
- University of Vermont and State Agricultural College
- Seattle Children's Hospital
- Providence Sacred Heart Medical Center and Children's Hospital
- West Virginia University Charleston Division
- Children's Hospital of Wisconsin
- The Children's Hospital at Westmead
- Westmead Hospital
- Princess Margaret Hospital for Children
- British Columbia Children's Hospital
- IWK Health Centre
- Centre Hospitalier Universitaire Sainte-Justine
- Saskatoon Cancer Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I (chemotherapy, immunoglobulin therapy)
Arm II (chemotherapy, observation)
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months. Patients receive immune globulin IV on days -2 and -1, at weeks 4, 8, 12, 16, 20, and 24, and then at months 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment.
Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months. Patients do not receive immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.