Neuroblastoma-Associated OMA Syndrome Treatment - Phase III

Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone

Protocol Description

The goal of this Children's Oncology Group, Phase III study is to determine whether intravenous gamma globulin (IVIG) improves neuroblastoma-associated opsoclonus-myoclonus-ataxia syndrome (OMA), a condition that includes abnormal eye movement, muscle twitching and abnormal motor coordination. It also evaluates long-term effects of OMA on children. The study uses drugs that suppress the immune system.

Eligibility Criteria

Boys and girls under 8 years old who have neuroblastoma-associated OMA will be eligible to participate.
Boys: Under age 8
Girls: Under age 8

All patients receive steroid and the chemotherapy cytoxan for the treatment of the OMA. Some patients may receive additional chemotherapy if their neuroblastoma requires more treatment.  Patients are then randomly assigned to receive or not receive IVIG, to determine if this medication adds to our ability to improve the long term effects of children with OMA.
Visits: Number to be determined by physician, based on patient’s condition and response to treatment.
Duration: Up to 18 months for the treatment regimen, with annual visits thereafter.

Status: Open for Enrollment

Source of Support
Children’s Oncology Group (Study ANBL00P3)
National Cancer Institute
Biopathology Center

Additional Resources
Children’s Oncology Group CureSearch
Study description at National Institutes of Health

Primary Investigator(s)

Jean M. Tersak, MD

Contact Information

To get started, please contact:
Jean M. Tersak, MD

Last Update
January 6, 2014
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Last Update
January 6, 2014