Full Text View
Tabular View
No Study Results Posted
Related Studies
Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma
This study is currently recruiting participants.
Study NCT00202930   Information provided by Tersak, Jean M., M.D.
First Received: September 12, 2005   Last Updated: September 19, 2006   History of Changes

September 12, 2005
September 19, 2006
July 2005
 
  • Feasibility and toxicity
  • Response
Same as current
Complete list of historical versions of study NCT00202930 on ClinicalTrials.gov Archive Site
Pharmacokinetic data and HACA development in the pediatric population
Same as current
 
Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma
Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma

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.

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.

Phase II
Interventional
Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
  • Neuroblastoma
  • Opsoclonus-Myoclonus
Drug: anti-CD20 (Rituximab)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
10
July 2008
 

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

-

Both
2 Months to 18 Years
No
Contact: Jean M. Tersak, MD 412-692-5055 jean.tersak@chp.edu
United States
 
NCT00202930
 
IRB# 0405652
Tersak, Jean M., M.D.
Genentech
Principal Investigator: Jean M Tersak, M.D. Children's Hospital of Pittsburgh Department of Hematology Oncology and BMT
Tersak, Jean M., M.D.
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP