Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma
- Sponsor
- Jean M. Tersak, M.D.
- Study ID
- NCT00202930
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Neuroblastoma
- Opsoclonus-myoclonus
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Months - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- anti-CD20 (Rituximab) — DRUG4 weekly doses of IV rituxan at 375 mg/m2 on days 1, 8, 15 and 22
Study Details
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.
Key Dates
- Start date
- Jul 31, 2005
- Status verified
- Jan 2021
- Primary completion
- Dec 31, 2008
- Completion
- Feb 5, 2009
Study Design
- Enrollment
- 4 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: RituximabSingle Arm
Primary Outcome Measure
Feasibility of Using 4 Weekly Rituximab Infusions [ Time Frame: 4 weeks ]
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