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

Not Recruiting

Trial ID: NCT00033293


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.

Official Title

A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone

Stanford Investigator(s)


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


other: clinical observation

biological: therapeutic immune globulin

drug: cyclophosphamide

drug: prednisone

procedure: magnetic resonance imaging

other: laboratory biomarker analysis

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Neyssa Marina

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