Trial record 8 of 58 for:    Paraneoplastic Syndromes

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.
Verified March 2014 by Institut Curie
Sponsor:
Information provided by (Responsible Party):
Institut Curie
ClinicalTrials.gov Identifier:
NCT01868269
First received: May 27, 2013
Last updated: March 13, 2014
Last verified: March 2014
  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 Pédiatric) 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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dexametasone 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01868269

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

Locations
France
Chu de Bicetre Not yet recruiting
Kremlin Bicetre, Kremlin Bicetre Cedex, France, 94275
Contact: TARDIEU Marc, dr         
Principal Investigator: TARDIEU MARC, DR         
Centre Oscar Lambret Not yet recruiting
Lille, Lille Cedex, France, 59020
Contact: DESFACHELLES THOMASSIN Anne-Sophie, DR         
Principal Investigator: DESFACHELLES THOMASSIN Anne-Sophie, DR         
Centre Leon Berard Not yet 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 Not yet recruiting
Nantes, NANTES Cedex01, France, 44093
Contact: THEBAUD Estelle, DR         
Principal Investigator: THEBAUD Estelle, DR         
Chu de Nice Archet 2 Not yet recruiting
Nice, Nice Cedex 03, France, 06202
Contact: LE MEIGNEN DIOP Marion, dr         
Principal Investigator: LE MEIGNEN DIOP Marion, DR         
Ch Trousseau Recruiting
Paris, PARIS Cedex 12, France, 75571
Contact: FASOLA Sylvie, dr         
Principal Investigator: FASOLA Sylvie, 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: MARIE CARDINE Aude, DR         
Principal Investigator: MARIE CARDINE AUDE, DR         
Institut de Cancerologie de La Loire Not yet recruiting
Saint Priest En Jarez, Saint Priest En Jarez Cedex, France, 42271
Contact: STEPHAN Jean-Louis, DR         
Principal Investigator: STEPHAN Jean-Louis, dr         
CHU DE STRASBOURG HOPITAL Hautepierre Not yet recruiting
Strasbourg, Strasbourg Cedex, France, 67098
Contact: LUTZ Patrick, dr         
Principal Investigator: LUTZ Patrick, dr         
Chu Toulouse Hopital Des Enfants Recruiting
Toulouse, TOULOUSE Cedex 9, France, 31059
Contact: RUBIE Hervé, dr         
Principal Investigator: RUBIE Hervé, 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: PLOUVIER Emmanuel, DR         
Principal Investigator: PLOUVIER Emmanuel, DR         
Chr Pellegrin Not yet recruiting
Bordeaux, France, 33076
Contact: ICHER Céline, DR         
Principal Investigator: 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: COUILLAULT Gérard, DR         
Principal Investigator: COUILLAULT Gérard, 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: GORDE GROJEAN Stéphanie, DR         
Principal Investigator: GORDE GROJEAN Stéphanie, dr         
Chu Tours Hopital Clocheville Not yet recruiting
Tours, France, 37044
Contact: BLOUIN Pascale, dr         
Principal Investigator: BLOUIN Pascale, dr         
Hopital Nancy Brabois Not yet recruiting
Vandoeuvre Les Nancy, France, 54500
Contact: CHASTAGNER PASCAL, DR         
Principal Investigator: CHASTAGNER Pascal, DR         
Institut de Cancerologie Gustave Roussy Not yet recruiting
Villejuif, France, 94805
Contact: VALTEAU COUANNET Dominique, dr         
Principal Investigator: VALTEAU COUANNET Dominique, DR         
Italy
G. Gaslini Institut Not yet recruiting
Genua, Italy, 16148
Contact: DE GRANDIS ELISA, DR         
Principal Investigator: DE GRANDIS Elisa, dr         
Sweden
University Hospital Lund Not yet recruiting
Lund, Sweden, 22185
Contact: ORA Ingrid, dr         
Principal Investigator: ORA Ingrid, dr         
United Kingdom
John Radcliffe Hospital Not yet 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

No publications provided

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: March 13, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Opsoclonus-Myoclonus Syndrome
Paraneoplastic Syndromes, Nervous System
Paraneoplastic Syndromes
Myoclonus
Neuroblastoma
Ocular Motility Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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
Central Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Nervous System Neoplasms
Neoplasms by Site
Neurodegenerative Diseases
Cyclophosphamide
Rituximab
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate

ClinicalTrials.gov processed this record on April 17, 2014