Opsoclonus Myoclonus Syndrome/Dancing Eye Syndrome (OMS/DES) in Children With and Without Neuroblastoma (NBpos and NBneg)Opsoclonus Myoclonus Syndrome/Dancing Eye Syndrome (OMS/DES) in Children With and Without Neuroblastoma (NBpos and NBneg)
NCT ID: NCT01868269
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
102 participants
INTERVENTIONAL
2013-04-18
2025-01-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dexamethasone Cyclophosphamide Rituximab
Dexamethasone acetate
First step:
immunosuppressive treatment with dexamethasone
dexamethasone and cyclophosphamide
second step (in case of insufficient response): immunosuppressive treatment with dexamethasone and cyclophosphamide
dexamethasone and rituximab
third step (in case of insufficient response): immunosuppressive treatment with dexamethasone and rituximab
Interventions
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Dexamethasone acetate
First step:
immunosuppressive treatment with dexamethasone
dexamethasone and cyclophosphamide
second step (in case of insufficient response): immunosuppressive treatment with dexamethasone and cyclophosphamide
dexamethasone and rituximab
third step (in case of insufficient response): immunosuppressive treatment with dexamethasone and rituximab
Eligibility Criteria
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Inclusion Criteria
Three out of the following four components are necessary for the diagnosis of OMS/DES:
* Opsoclonus or ocular flutter (but not nystagmus)
* Ataxia and/or myoclonus
* Behavioural change and/or sleep disturbance
* Neuroblastoma The diagnosis of OMS/DES may be difficult in some patients. Opsoclonus, in particular, may be intermittent or late in onset. A video example will be available at www.dancingeyes.org.uk. If uncertain, please contact the national coordinator for support in interpreting clinical features.
* Age 6 months or over up to less than 8 years (\< 8th birthday) The date of diagnosis of OMS/DES is the date on which a doctor confirms the condition to be OMS/DES. The date of symptom onset needs also to be documented.
* Treatment start with the standard corticosteroid treatment with dexamethasone pulses as proposed by the guidelines given in this trial protocol (see 11.10, page 71).
* In patients with presumed NB-neg OMS/DES, neuroblastoma must be excluded according the guidelines of this trial (see chapter 4.4.1.4, page 30, and appendix 11.9, page 70)
* Documented informed consent for treatment and enrolment in the trial by parents / legal representatives.
Exclusion Criteria
An identified viral precursor is not an exclusion criterion.
* prior or parallel use of chemotherapy (other than required for treatment of the neuroblastoma)
* Corticoid steroid for OMS/DES or other reasons lasting 14 days or more immediately before treatment start according the standard treatment proposed (treatment with corticosteroids for less than 14 days will be allowed)
* contre-indication of use of one of the experimental study drug (cf Summary of Product Characteristics used in this study)
6 Months
8 Years
ALL
No
Sponsors
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Institut Curie
OTHER
Responsible Party
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Principal Investigators
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Gudrun Schleiermacher, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Curie
Locations
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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
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
Chu de Rouen
Rouen, Rouen Cedex, France
CHU DE STRASBOURG HOPITAL Hautepierre
Strasbourg, Strasbourg Cedex, France
Chu Toulouse Hopital Des Enfants
Toulouse, Toulouse Cedex 9, France
Chu Amiens
Amiens, , France
Chu Angers
Angers, , France
Hopital Jean Minjoz
Besançon, , France
Chr Pellegrin
Bordeaux, , France
CHU CAEN
Caen, , France
Chu D'Estaing
Clermont-Ferrand, , France
Chu Dijon
Dijon, , France
Chu de Grenoble
Grenoble, , France
Chu de Limoges
Limoges, , France
Institut Curie
Paris, , France
Chu de Poitiers
Poitiers, , France
Chu de Reims
Reims, , France
CHU LA REUNION Site Félix Guyon
Saint-Denis, , France
Chu Saint Etienne
Saint-Etienne, , France
Chu Tours Hopital Clocheville
Tours, , France
Hopital Nancy Brabois
Vandœuvre-lès-Nancy, , France
Institut de Cancerologie Gustave Roussy
Villejuif, , France
G. Gaslini Institut
Genova, , Italy
The Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
El Palmar, , Spain
University Hospital Lund
Lund, , Sweden
Universitätskinderklinik
Bern, , Switzerland
Kinderspital Zurich
Zurich, , Switzerland
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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Other Identifiers
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IC 2011-02
Identifier Type: -
Identifier Source: org_study_id
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