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Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma

NCT00202930 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-01-22

Study results available
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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.

Conditions

Interventions

DRUG

anti-CD20 (Rituximab)

4 weekly doses of IV rituxan at 375 mg/m2 on days 1, 8, 15 and 22

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Jean M. Tersak, M.D.

    lead OTHER

Principal Investigators

  • Jean M Tersak, M.D. · Children's Hospital of Pittsburgh Department of Hematology Oncology and BMT

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2008-12-31
Completion
2009-02-05

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00202930 on ClinicalTrials.gov