Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma

Completed · Phase 3

Conditions studied: Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Regional Neuroblastoma, Stage 4 Neuroblastoma, Stage 4S Neuroblastoma

In brief

This randomized phase III trial is studying cyclophosphamide, prednisone, and immunoglobulin to see how well they work compared to cyclophosphamide and prednisone alone in treating patients with abnormal trunk muscle movements associated with neuroblastoma. Drugs used in chemotherapy, work in different ways to stop tumor cells from dividing so they stop growing or die. Steroid therapy decreases inflammation. Combining chemotherapy and steroid therapy with immunoglobulin may be effective in treating abnormal muscle movement associated with neuroblastoma.

Key facts

Study ID

NCT00033293

Run by

Children's Oncology Group

People needed

53

Starts

2004-03-15

Expected to finish

2022-12-31

Last updated by the study team

2023-04-18

Who can join

Age: any, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• Kaiser Permanente-Oakland — Oakland, 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-Mount Zion — San Francisco, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• Harbor-University of California at Los Angeles Medical Center — Torrance, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
• Connecticut Children's Medical Center — Hartford, 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
• Lee Memorial Health System — Fort Myers, 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
• Nemours Children's Clinic - Orlando — Orlando, Florida, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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