At a glance
ClinicalIndex Comparison Record- ✓Newly diagnosed neuroblastoma or ganglioneuroblastoma with tumor-associated opsoclonus-myoclonus-ataxia syndrome (OMA)
- ✓Diagnosed with NBL within 6 months of OMA diagnosis OR OMA diagnosed within 6 months of NBL diagnosis
- ✓Must enroll on study within 4 weeks of diagnosis
- ✓Currently enrolled on COG neuroblastoma protocols: COG-ANBL00B1 or its successor
- ✕Prior IV gamma globulin therapy
- ✕Prior chemotherapy
- ✕Prior prednisone or corticotropin therapy (except ≤14 days of steroids)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone
In Brief
A Phase 3 clinical trial evaluating Clinical Observation, Cyclophosphamide, and 4 other interventions for Localized Resectable Neuroblastoma and 4 related conditions. Completed, enrolled 53 participants across 104 sites in 3 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Undergo observation
Given IV
Correlative studies
Correlative studies
Given orally
Given IV