Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma

Primary Outcomes (2)

• Feasibility of Using 4 Weekly Rituximab Infusions

  To evaluate the feasibility of using 4 weekly Rituximab infusions in the treatment of children with neuroblastoma associated opsoclonus-myoclonus syndrome (OMS). The first infusion involved a slow up titration from an initial rate of 0.5 mg/kg/hour to a maximum of 400 mg/hour. If well tolerated, the subsequent infusions were administered at a starting rate of 1 mg/kg/hour to a maximum of 100 mg/hour for the first hour. In the absence of adverse reaction doses were escalated by 1 mg/kg/hour (maximum 100 mg increase per hour) every 30 minutes to a maximum rate of 400 mg/hour. If hypersensitivity or infusion related events occurred, the infusion was temporarily interrupted and resumed at 50% of the previous rate if reaction resolves. The number of participants for whom the study dosing was feasible is reported.

  4 weeks

• Toxicity of Rituximab

  The trial was to be terminated early for any grade 3 or 4 toxicity that did not resolve in 2 of the first 5 patients treated, or for any infusion related death. The number of participants who experienced these events \[grade 3 or 4 toxicity that did not resolve in 2 of the first 5 patients treated, or for any infusion related death\] is reported.

  Individuals were followed for adverse events until day 270

Conditions