Status:
TERMINATED
Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma
Lead Sponsor:
Jean M. Tersak, M.D.
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Neuroblastoma
Opsoclonus-myoclonus
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
Brief 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-...
Detailed Description
Opsoclonus-myoclonus ataxia syndrome (OMS) is a rare immune mediated paraneoplastic syndrome that occurs in approximately 2 to 3% of children with neuroblastoma. Children with neuroblastoma associated...
Eligibility Criteria
Inclusion
- 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
- 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
- \-
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00202930
Start Date
July 1 2005
End Date
February 5 2009
Last Update
January 22 2021
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