Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma
|ClinicalTrials.gov Identifier: NCT00202930|
Recruitment Status : Unknown
Verified September 2006 by Tersak, Jean M., M.D..
Recruitment status was: Recruiting
First Posted : September 20, 2005
Last Update Posted : September 20, 2006
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma Opsoclonus-Myoclonus||Drug: anti-CD20 (Rituximab)||Phase 2|
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 opsoclonus-myoclonus tend to have a favorable prognosis from the standpoint of the cure of their cancer. Unfortunately,approximately two-thirds of this subgroup of patients are left with long term sequellae of the syndrome, including residual symptoms of opsoclonus, myoclonus, ataxia, learning difficulties and disturbance of sleep and mood.
Multiple lines of evidence indicate an immune mechanism to this rare disorder. This includes occurence of OMS in the post-infectious state, aggressive lymphocytic infiltration of the tumor in children with OMS, and documented responses to therapries that act through suppression of the immune system.
The current study utilizes four weekly doses of anti-CD 20 antibody (rituximab) to treat children with refractory OMS. Refractory disease is defined as continued symptoms of OMS despite surgical resection of the tumor and a minimum of one month of steroid therapy.
All patients have baseline OMS evaluation and detailed neurocognitive testing with all studies being repeated at the completion of the four weekly infusions. OMS testing is repeated at Month 3. OMS testing and detailed neurocognitive testing is conducted at 6 months intervals until 2 years from the initial infusion.
The goal of the study is to utilize this novel therapy to improve long term neurologic and neurodevelopmental outcome in children with refratory neuroblastoma associated opsoclonus-myoclonus.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma|
|Study Start Date :||July 2005|
|Estimated Study Completion Date :||July 2008|
- Feasibility and toxicity
- Pharmacokinetic data and HACA development in the pediatric population
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202930
|Contact: Jean M. Tersak, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Jean M Tersak, MD 412-692-5055 email@example.com|
|Contact: Nina F Schor, MD, PhD 412-692-5528 firstname.lastname@example.org|
|Principal Investigator: Jean M Tersak, MD|
|Principal Investigator:||Jean M Tersak, M.D.||Children's Hospital of Pittsburgh Department of Hematology Oncology and BMT|