Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma
Condition: Localized Resectable Neuroblastoma; Localized Unresectable Neuroblastoma; Regional Neuroblastoma; Stage 4 Neuroblastoma; Stage 4S Neuroblastoma
MeSH terms: Neuroblastoma
Intervention: Clinical Observation; Cyclophosphamide; Laboratory Biomarker Analysis; Magnetic Resonance Imaging; Prednisone; Therapeutic Immune Globulin
Intervention description: Undergo observation; Given IV; Correlative studies; Correlative studies; Given orally; Given IV
Intervention MeSH terms: Prednisone; Cortisone; Cyclophosphamide; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin; Immunoglobulin G
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Maximum age: 8 Years
Healthy volunteers: No

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.
    

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