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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	20 February 2017
Main ID:	EUCTR2006-001489-17-ES
Date of registration:	22/02/2008
Prospective Registration:	Yes
Primary sponsor:	Victoria Castel Sánchez
Public title:	Anticuerpo monoclonal recombinante antiGDch14.18. Estudio 1 de Neuroblastoma de Alto Riesgo de la SIOP-Europa. Recombination Chimeric Monoclonal Antibody CH.14.18 - ch14.18
Scientific title:	Anticuerpo monoclonal recombinante antiGDch14.18. Estudio 1 de Neuroblastoma de Alto Riesgo de la SIOP-Europa. Recombination Chimeric Monoclonal Antibody CH.14.18 - ch14.18
Date of first enrolment:	10/02/2010
Target sample size:	630
Recruitment status:	Authorised-recruitment may be ongoing or finished
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001489-17
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: ácido 13-cis retinoico solo (estandard) frente a ácido 13-cis retinoico + anticuerpo ch14.18
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
Austria	Belgium	Denmark	Finland	Greece	Hungary	Poland	Slovenia
Spain

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
Pacientes incluidos en el Estudio de Neuroblastoma de Alto Riesgo que tengan firmado el consentimiento informado para R2 y que cumplen con los criterios de inclusión para R2 (participación en R1, o lactantes con amplificación de N-myc y Bumel electivo, reestadiaje completo de la enfermedad tras el trasplante, recuperación de toxicidades mayores relacionadas con el mismo y finalización de la radioterapia local. Buen estado de salud y sin signos clínicos y analíticos de infección)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Cualquier respuesta negativa a los criterios de inclusión detallados en E3 será motivo de exclusión

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Nueroblastoma (Nb) Enfermos afectos de Nb de alto riesgo (Nb estadio 4 mayores de 1 año y Nb estadios 2, 3, 4 con amplificación N-myc). Neuroblastoma (Nb) patients with high risk neuroblastoma (stage 4 Nb in children over one year, stages 2, 3 and 4 with N-myc amplification)
MedDRA version: 9 Level: LLT Classification code 10029260 Term: Neuroblastoma
MedDRA version: 9 Level: PT Classification code 10029260

Intervention(s)

Product Name: anticuerpo monoclonal quimérico recombinante ch14.18
Product Code: ch14.18
Pharmaceutical Form: Solution for injection
INN or Proposed INN: recombinant monoclonal antibody ch14.18
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 4.5-

Primary Outcome(s)

Primary end point(s): Estadio, Amplificación de N-myc, Edad

Main Objective: Demostrar si la adición del anticuerpo ch14.18 al ácido 13-cis retinoico mejpra la SLE (supervivencia libre de enfermedad) a 3 años en pacientes con Neuroblastoma de Alto Riesgo

Secondary Objective: Determinar la tolerancia del ácido 13-cis retinoico tras el trasplante con y sin la adición de inmunoterapia con el anticuerpo monoclonal quimérico recombinante ch14.18

Secondary Outcome(s)

Secondary ID(s)

2006-001489-17-AT

SIOPENRNET002

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
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