Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202930
Status:
TERMINATED
Last Update Posted:
2021-01-22
First Post:
2005-09-12
Brief Title:
Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma
Sponsor:
Jean M Tersak MD
Organization:
University of Pittsburgh
Study Overview
Official Title:
Use of Rituximab in Opsoclonus-Myoclonus in Children With Neuroblastoma
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed early due to low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 Unfortunatelyapproximately 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None