Overview

Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma

Status:
Terminated

Trial end date:
2009-02-05

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to evaluate the feasibility of giving four weekly doses of Rituximab (anti-CD20 antibody) in the treatment of children with refractory neuroblastoma associated opsoclonus-myoclonus. Patients must have continued symptoms of opsoclonus, myoclonus and or ataxia despite surgical resection and a minimum of one month of steroid therapy. Evaluations include clinical symptoms of opsoclonus-myoclonus and ataxia as well as detailed evaluation of learning and development.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Jean M. Tersak, M.D.
Tersak, Jean M., M.D.

Collaborator:

Genentech, Inc.

Treatments:

Rituximab

Criteria

Inclusion Criteria:

Pathologic confirmation of diagnosis of neuroblastoma Surgical resection of primary tumor
Symptoms of OMS despite a minimum of one month of steroid therapy Must meet all laboratory
criteria to demonstrate adequate organ function -

Exclusion Criteria:

Patients currently receiving systemic chemotherapy for treatment of neuroblastoma Patients
with documented active infection Patients who are HIV, Hep B or Hep C positive Organ
toxicity from any prior therapy or surgical intervention must be resolved prior to study
entry

-