TerminatedPhase 2

Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma

Stopped: Closed early due to low accrual.

4 participantsStarted 2005-07

Plain-language 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.

Who can participate

Age range2 Months – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \-

What they're measuring

Feasibility of Using 4 Weekly Rituximab Infusions

Timeframe: 4 weeks

Toxicity of Rituximab

Timeframe: Individuals were followed for adverse events until day 270

Trial details

NCT IDNCT00202930

SponsorJean M. Tersak, M.D.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-12

Results submitted2021-01-04

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