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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Institut Curie
Sponsor:
Information provided by (Responsible Party):
Institut Curie
ClinicalTrials.gov Identifier:
NCT01868269
First received: May 27, 2013
Last updated: September 15, 2017
Last verified: September 2017
  Purpose

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.


Condition Intervention Phase
Opsoclonus Myoclonus Syndrome Neuroblastoma Drug: Dexamethasone acetate Drug: dexamethasone and cyclophosphamide Drug: dexamethasone and rituximab Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multinational European Trial for Children With the Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome

Resource links provided by NLM:


Further study details as provided by Institut Curie:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Actual Study Start Date: April 18, 2013
Estimated Study Completion Date: April 2031
Estimated Primary Completion Date: February 2027 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dexamethasone Cyclophosphamide Rituximab Drug: Dexamethasone acetate

First step:

immunosuppressive treatment with dexamethasone

Drug: dexamethasone and cyclophosphamide
second step (in case of insufficient response): immunosuppressive treatment with dexamethasone and cyclophosphamide
Drug: dexamethasone and rituximab
third step (in case of insufficient response): immunosuppressive treatment with dexamethasone and rituximab

  Eligibility

Ages Eligible for Study:   6 Months to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with newly diagnosed OMS/DES either NB-pos or NB-neg.

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:

•Patients with opsoclonus, myoclonus or ataxia caused by other identified disease (e.g. current active CNS infection, neurometabolic disorder or demyelination).

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01868269

Contacts
Contact: Patricia TRESCA, MD +33156245765 emmanuelle.bouffier@curie.fr

Locations
Austria
St. Anna Kinderkrebsforschung e.V. CHILDREN'S CANCER RESEARCH INSTITUTE Recruiting
Wien, Austria, 1090
Principal Investigator: Ruth LADENSTEIN, Dr.         
France
Chu de Bicetre Recruiting
Le Kremlin-Bicêtre, Le Kremlin Bicetre, France, 94275
Contact: DEIVA Kumaran, dr         
Principal Investigator: DEIVA Kumaran, DR         
Centre Oscar Lambret Recruiting
Lille, Lille Cedex, France, 59020
Contact: DESFACHELLES THOMASSIN Anne-Sophie, DR         
Principal Investigator: DESFACHELLES THOMASSIN Anne-Sophie, DR         
Centre Leon Berard Recruiting
Lyon, Lyon Cedex 08, France, 69373
Contact: FAURE CONTER Cécile, DR         
Principal Investigator: FAURE CONTER Cécile, DR         
Hopita D'Enfants de La Timone Recruiting
Marseille, Marseille Cedex 5, France, 13385
Contact: COZE CAROLE, DR         
Principal Investigator: COZE Carole, DR         
Hopital Arnaud de Villeneuve Not yet recruiting
Montpellier, Montpellier Cedex 4, France, 34295
Contact: HAOUY Stéphanie, DR         
Principal Investigator: HAOUY Stéphanie, DR         
Chr de Nantes Recruiting
Nantes, NANTES Cedex01, France, 44093
Contact: THEBAUD Estelle, DR         
Principal Investigator: THEBAUD Estelle, DR         
Chu de Nice Archet 2 Recruiting
Nice, Nice Cedex 03, France, 06202
Contact: BENADIBA Joy, dr         
Principal Investigator: BENADIBA Joy, DR         
Ch Trousseau Recruiting
Paris, PARIS Cedex 12, France, 75571
Contact: PETIT Arnaud, dr         
Principal Investigator: PETIT Arnaud, dr         
Chu Hopital Sud Not yet recruiting
Rennes, Rennes Cedex 02, France, 35056
Contact: TAQUE Sophie, dr         
Principal Investigator: TAQUE Sophie, dr         
Chu de Rouen Not yet recruiting
Rouen, Rouen Cedex, France, 76031
Contact: SCHNEIDER Pascale, DR         
Principal Investigator: SCHNEIDER Pascale, DR         
CHU DE STRASBOURG HOPITAL Hautepierre Not yet recruiting
Strasbourg, Strasbourg Cedex, France, 67098
Contact: Natacha ENTZ-WERLE, MD         
Principal Investigator: Natacha ENTZ-WERLE, MD         
Chu Toulouse Hopital Des Enfants Recruiting
Toulouse, TOULOUSE Cedex 9, France, 31059
Contact: Marion GAMBART, dr         
Principal Investigator: Marion GAMBART, dr         
Chu Amiens Not yet recruiting
Amiens, France, 80054
Contact: DEVOLDERE Catherine, DR         
Principal Investigator: DEVOLDERE Catherine, DR         
Chu Angers Not yet recruiting
Angers, France, 49933
Contact: PELLIER Isabelle, DR         
Principal Investigator: PELLIER Isabelle, DR         
Hopital Jean Minjoz Not yet recruiting
Besancon, France, 25030
Contact: KLEIN Stéphane, DR         
Principal Investigator: KLEIN Stéphane, DR         
Chr Pellegrin Recruiting
Bordeaux, France, 33076
Contact: BOUYN-ICHER Céline, DR         
Principal Investigator: BOUYN-ICHER Céline, DR         
CHU CAEN Not yet recruiting
Caen, France, 14033
Contact: MINCKES ODILE, DR         
Principal Investigator: MINCKES Odile, DR         
Chu D'Estaing Not yet recruiting
Clermont Ferrand, France, 63003
Contact: KANOLD Justina, DR         
Principal Investigator: KANOLD Justina, DR         
Chu Dijon Not yet recruiting
Dijon, France, 21079
Contact: BOTTOLLIER COLOMB Elodie, DR         
Principal Investigator: BOTTOLLIER COLOMB Elodie, DR         
Chu de Grenoble Recruiting
Grenoble, France, 38045
Contact: PLANTAZ Dominique, DR         
Principal Investigator: PLANTAZ Dominique, DR         
Chu de Limoges Not yet recruiting
Limoges, France, 87042
Contact: PIGUET Christophe, DR         
Principal Investigator: PIGUET Christophe, DR         
Institut Curie Recruiting
Paris, France, 75005
Contact: Schleiermacher Gudrun, dr         
Principal Investigator: Schleiermacher Gudrun, dr         
Chu de Poitiers Not yet recruiting
Poitiers, France, 86021
Contact: MILLOT Frédéric, DR         
Principal Investigator: MILLOT Frédéric, dr         
Chu de Reims Not yet recruiting
Reims, France, 51092
Contact: PLUCHART Claire, DR         
Principal Investigator: PLUCHART Claire, dr         
CHU LA REUNION Site Félix Guyon Recruiting
Saint-denis, France, 97400
Principal Investigator: Yves REGUERRE, MD         
Chu Saint Etienne Not yet recruiting
Saint-Étienne, France, 42055
Contact: STEPHAN Jean-Louis, DR         
Principal Investigator: STEPHAN Jean-Louis, dr         
Chu Tours Hopital Clocheville Not yet recruiting
Tours, France, 37044
Contact: BLOUIN Pascale, dr         
Principal Investigator: BLOUIN Pascale, dr         
Hopital Nancy Brabois Recruiting
Vandoeuvre Les Nancy, France, 54500
Contact: CHASTAGNER PASCAL, DR         
Principal Investigator: CHASTAGNER Pascal, DR         
Institut de Cancerologie Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: VALTEAU COUANNET Dominique, dr         
Principal Investigator: VALTEAU COUANNET Dominique, DR         
Italy
G. Gaslini Institut Recruiting
Genova, Italy, 16148
Contact: DE GRANDIS ELISA, DR         
Principal Investigator: DE GRANDIS Elisa, dr         
Spain
The Fundación para la Formación e Investigación Sanitarias de la Región de Murcia Recruiting
El Palmar, Spain, 30120
Principal Investigator: Mar Bermúdez Cortés, Dr.         
Sweden
University Hospital Lund Recruiting
Lund, Sweden, 22185
Contact: ORA Ingrid, dr         
Principal Investigator: ORA Ingrid, dr         
Switzerland
Universitätskinderklinik Recruiting
Bern, Switzerland, CH 3010
Principal Investigator: Maja STEINLIN, DR         
Kinderspital Zurich Recruiting
Zurich, Switzerland, 8032
Principal Investigator: Andrea KLEIN         
United Kingdom
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, 0X3 9DU
Contact: PIKE Michael, dr         
Principal Investigator: PIKE Michael, dr         
Sponsors and Collaborators
Institut Curie
Investigators
Principal Investigator: Gudrun Schleiermacher, MD Institut Curie
  More Information

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT01868269     History of Changes
Other Study ID Numbers: IC 2011-02
Study First Received: May 27, 2013
Last Updated: September 15, 2017

Additional relevant MeSH terms:
Syndrome
Opsoclonus-Myoclonus Syndrome
Paraneoplastic Syndromes, Nervous System
Paraneoplastic Syndromes
Neuroblastoma
Myoclonus
Ocular Motility Disorders
Disease
Pathologic Processes
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Nervous System Neoplasms
Neoplasms by Site
Neurodegenerative Diseases
Dexamethasone acetate
Dexamethasone

ClinicalTrials.gov processed this record on September 21, 2017