The OMS/DES study is a multinational European Trial for Children with the Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome. This trial brought on the way by specialists of the EPNS (European Paediatric Neurology Society), the GPOH (Gesellschaft für Pädiatrische Hematologic und Oncologie) and the SIOPEN (SIOP (International Society Oncology Pediatric) Europe Neuroblastoma). This protocol will investigate an escalating treatment schedule starting with a corticosteroid standard treatment with dexamethasone pulses (first step), which is followed, if response has been inadequate after 3 months of treatment, by the addition of CP (second step) and, if still no sufficient improvement, by the replacement of CP by Rituximab (third step). Treatment intensification is decided on the basis of standardized scoring of OMS/DES severity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
First step: immunosuppressive treatment with dexamethasone
second step (in case of insufficient response): immunosuppressive treatment with dexamethasone and cyclophosphamide
third step (in case of insufficient response): immunosuppressive treatment with dexamethasone and rituximab
St. Anna Kinderkrebsforschung e.V. CHILDREN'S CANCER RESEARCH INSTITUTE
Vienna, Austria
Chu de Bicetre
Le Kremlin-Bicêtre, LE Kremlin Bicetre, France
Centre Oscar Lambret
Lille, Lille Cedex, France
Centre Leon Berard
Lyon, LYON Cedex 08, France
Hopita D'Enfants de La Timone
Marseille, Marseille Cedex 5, France
The response to treatment schedule as defined by the percentage of patients with disappearance of all symptoms.
Time frame: at 48 weeks after treatment start
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Hopital Arnaud de Villeneuve
Montpellier, Montpellier Cedex 4, France
Chr de Nantes
Nantes, Nantes Cedex01, France
Chu de Nice Archet 2
Nice, NICE Cedex 03, France
Ch Trousseau
Paris, Paris Cedex 12, France
Chu Hopital Sud
Rennes, Rennes Cedex 02, France
...and 26 more locations