Trial Search Results

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

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 eye and trunk muscle movements (known as opsoclonus myoclonus ataxia) 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. Chemotherapy(cyclophosphamide), prednisone and intravenous gamma globulin all suppress the immune system which may be helpful in treating opsoclonus-myoclonus-ataxia (OMA).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Biological: therapeutic immune globulin
  • Other: clinical observation
  • Drug: cyclophosphamide
  • Drug: prednisone
  • Procedure: magnetic resonance imaging
  • Other: laboratory biomarker analysis
  • Drug: Corticotropin-Releasing Hormone

Phase:

Phase 3

Eligibility


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

   - 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

   - Patients must be free of any organ dysfunction or disorder that the treating physician
   feels may preclude the use of corticosteroid therapy (ACTH or prednisone),
   cyclophosphamide therapy or intravenous gammaglobulin therapy.

Ages Eligible for Study

N/A - 8 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Neyssa Marina
6507235535
Not Recruiting