Actively Recruiting
High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)
Led by St. Anna Kinderkrebsforschung · Updated on 2020-10-23
3300
Participants Needed
126
Research Sites
1282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non amplified \> 12 months at diagnosis). The protocol consists of a rapid, dose intensive induction chemotherapy, peripheral blood stem cell harvest, attempted complete excision of the primary tumour, myeloablative therapy followed by peripheral blood stem cell rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomization - isotretinoin and ch14.18/CHO (Dinutuximab beta, Qarziba ®).), with or without s.c. aldesleukin (IL-2)). Patients diagnosed after the closure of R3 randomization will not be R4 randomized. For these patients the use of ch14.18/CHO antibody is recommended without scIL-2 as continuous infusion as standard of care outside of controlled trials. ch14.18/CHO received marketing authorization by EMA in May 2017 (Qarziba ®). In the induction phase, all patients receive Rapid COJEC following the result of the R3 randomization which was closed on June 8th, 2017 after inclusion of 630 patients as planned. Following induction treatment peripheral blood stem cell harvest (PBSCH) is performed and complete excision of the primary tumour will be attempted. Patients with an inadequate metastatic response to allow BuMel MAT followed by PBSCR at the end of induction should receive 2 TVD (Topotecan, Vincristine, Doxorubicin) cycles. After Rapid COJEC induction, localized patients will proceed to consolidation. Patients aged 12-18 months at diagnosis, with stage 4 neuroblastoma, no MYCN amplification and without segmental chromosomal alterations (SCAs) are thought to have a good prognosis and will stop treatment after induction therapy and surgery to the primary tumour. Consolidation consists of BuMel MAT based on the results of the R1 randomization followed by peripheral blood stem cell rescue (PBSCR) and radiotherapy to the site of the primary tumour. The R2 immunotherapy randomization using ch14.18/CHO as 8 hour infusion on 5 consecutive days ( total dose (100mg/m²) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) is closed. The amended R4 immunotherapy randomization using ch14.18/CHO as continuous infusion (total dose 100mg/m² over 10 days) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) has accrued according to plan with results pending awaiting data maturity and DMC approval.
CONDITIONS
Official Title
High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of neuroblastoma according to the International Neuroblastoma Staging System (INSS).
- Age below 21 years.
- High-risk neuroblastoma defined as either INSS stage 2, 3, 4, or 4s with MYCN amplification, or INSS stage 4 without MYCN amplification for patients older than 12 months at diagnosis.
- No previous chemotherapy except for one cycle of etoposide and carboplatin.
- Written informed consent including parental or guardian agreement for minors.
- Tumor cell material available for biological prognostic testing.
- Female patients of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
- Female patients who are breastfeeding must agree to stop nursing.
- Registration of eligibility criteria within 6 weeks from diagnosis.
- Agreement to provisional follow-up for 5 years.
- Approval by national and local ethical committees.
You will not qualify if you...
- Any negative answer to the inclusion criteria.
AI-Screening
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Trial Site Locations
Total: 126 locations
1
Women and Children´s Hospital
Adelaide, Australia
Actively Recruiting
2
Lady Cilento Children´s Hospital
Brisbane, Australia
Actively Recruiting
3
John Hunter Children's Hospital
Newcastle, Australia
Actively Recruiting
4
Royal Children's Hospital Melbourne
Parkville, Australia
Actively Recruiting
5
Sydney Children's Hospital
Sydney, Australia
Actively Recruiting
6
Children´s Hospital Westmead
Westmead, Australia
Actively Recruiting
7
St. Anna Kinderspital
Vienna, Austra, Austria, 1090
Actively Recruiting
8
Univ.-Klinik für Kinder- und Jugendheilkunde Graz
Graz, Austria
Actively Recruiting
9
Univ.Klinik f. Kinder-u. Jugendheilkunde Innsbruck
Innsbruck, Austria
Actively Recruiting
10
Landes- Kinderklinik Linz
Linz, Austria
Actively Recruiting
11
St. Johanns Spital LKH Salzburg
Salzburg, Austria
Actively Recruiting
12
Cliniques universitaires St-Luc
Brussels, Belgium
Actively Recruiting
13
Hôpital des Enfants
Brussels, Belgium
Actively Recruiting
14
University Hospital Gent
Ghent, Belgium
Actively Recruiting
15
UZ Gasthuisberg
Leuven, Belgium
Actively Recruiting
16
CHR Citadelle
Liège, Belgium
Actively Recruiting
17
Clinique de l'Espérance
Montegnée, Belgium
Actively Recruiting
18
University Hospital Motol
Prague, Czechia
Actively Recruiting
19
Aarhus Universitetshospital
Aarhus, Denmark
Actively Recruiting
20
National State Hospital
Copenhagen, Denmark
Actively Recruiting
21
University Hospital of Odense
Odense, Denmark
Actively Recruiting
22
Skejby Hospital
Skejby, Denmark
Actively Recruiting
23
Hopital d'Enfants Dijon
Dijon, France
Actively Recruiting
24
CHU de Grenoble
Grenoble, France
Actively Recruiting
25
CHR Pellegrin
Le Pellerin, France
Actively Recruiting
26
Centre Oscar Lambret de Lille
Lille, France
Actively Recruiting
27
Hopitaux de Marseille La Timone
Marseille, France
Actively Recruiting
28
CHR de Nantes
Nantes, France
Actively Recruiting
29
Hôpital Trousseau Paris
Paris, France
Actively Recruiting
30
Institut Curie
Paris, France
Actively Recruiting
31
Hôpital American Memorial Hospital
Reims, France
Actively Recruiting
32
CHU-Saint Etienne
Saint-Etienne, France
Actively Recruiting
33
Hôpital de Hautepierre
Strasbourg, France
Actively Recruiting
34
Hôpital D'Enfants de Toulouse
Toulouse, France
Actively Recruiting
35
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
36
"A&P Kyriakou" Children's Hospital
Athens, Greece
Actively Recruiting
37
Aghia Sophia Children's Hospital
Athens, Greece
Actively Recruiting
38
MITERA Hospital
Heraklion, Greece
Actively Recruiting
39
PEPAGNH University Hospital
Heraklion, Greece
Actively Recruiting
40
Madarász Children Hospital Budapest
Budapest, Hungary
Actively Recruiting
41
Semmelweis University of Budapest
Budapest, Hungary
Actively Recruiting
42
University of Debrecen
Debrecen, Hungary
Actively Recruiting
43
University of Pecs
Pécs, Hungary
Actively Recruiting
44
University of Szeged
Szeged, Hungary
Actively Recruiting
45
Dublin: OLHSC
Dublin, Ireland
Actively Recruiting
46
Rambam Medical Centre
Haifa, Israel
Actively Recruiting
47
Schneider Children's Medical Center of Israel
Petah Tikva, Israel
Actively Recruiting
48
Sheba Medical Center
Tel Aviv, Israel
Actively Recruiting
49
Ospedale G. Salesi
Ancona, Italy
Actively Recruiting
50
Universitŕ degli studi di Bari
Bari, Italy
Actively Recruiting
51
Ospedali Riuniti
Bergamo, Italy
Actively Recruiting
52
Ospedale S. Orsola
Bologna, Italy
Actively Recruiting
53
Ospedale Regionale per le Microcitemie
Cagliari, Italy
Actively Recruiting
54
Azienda Ospedaliera di Cosenza
Cosenza, Italy
Actively Recruiting
55
Azienda Ospedaliera A. Meyer
Florence, Italy
Actively Recruiting
56
Istituto Giannina Gaslini
Genoa, Italy
Actively Recruiting
57
Istituto Nazionale Tumori di Milano
Milan, Italy
Actively Recruiting
58
Azienda Ospedal. Univ. di Modena
Modena, Italy
Actively Recruiting
59
Sec. Univ. degli Studi di Napoli - Policlinico
Naples, Italy
Actively Recruiting
60
Clinica di Oncoematologia Pediatrica Padova
Padova, Italy
Actively Recruiting
61
Ospedale dei Bambini, Palermo
Palermo, Italy
Actively Recruiting
62
Azienda Ospedaliera Universitaria di Parma-Oncoematologia Pediatrica
Parma, Italy
Actively Recruiting
63
Policlinico San Matteo
Pavia, Italy
Actively Recruiting
64
Ospedale Civile Spirito Santo
Pescara, Italy
Actively Recruiting
65
Ospedale "Infermi "
Rimini, Italy
Actively Recruiting
66
Policlinico Borgo Roma
Roma, Italy
Actively Recruiting
67
Ospedale Bambino Gesu
Rome, Italy
Actively Recruiting
68
Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
Actively Recruiting
69
O.I.R.M. - S. Anna
Torino, Italy
Actively Recruiting
70
Istituto per l'Infanzia "Burlo Garofolo"
Trieste, Italy
Actively Recruiting
71
Haukeland University Hospital
Bergen, Norway
Actively Recruiting
72
Rikshospitalet
Oslo, Norway
Actively Recruiting
73
University Hospital of North-Norway
Tromsø, Norway
Actively Recruiting
74
Medical University of Bialystok
Bialystok, Poland
Actively Recruiting
75
Medical University of Bydgoszcz
Bydgoszcz, Poland
Actively Recruiting
76
Childrens' Hospital in Chorzów
Chorzów, Poland
Actively Recruiting
77
Medical University in Gdansk
Gdansk, Poland
Actively Recruiting
78
Upper Silesian Centre of Child and Mother's Care
Katowice, Poland
Actively Recruiting
79
University Children's Hospital
Krakow, Poland
Actively Recruiting
80
Children's University Hospital in Lublin
Lublin, Poland
Actively Recruiting
81
University of Medical Sciences Poznan
Poznan, Poland
Actively Recruiting
82
Institute Mother and Child
Warsaw, Poland
Actively Recruiting
83
Wroclaw Medical University
Wroclaw, Poland
Actively Recruiting
84
Ipofg-Crl
Lisbon, Portugal
Actively Recruiting
85
University Hospital F. D. Roosevelt
Banská Bystrica, Slovakia
Actively Recruiting
86
University Children's Hospital Ljubljana
Ljubljana, Slovenia, 10000
Actively Recruiting
87
H . Materno-Infantil Teresa Herrera
A Coruña, Spain
Actively Recruiting
88
H. General de Alicante
Alicante, Spain
Actively Recruiting
89
Hospital Vall d'Hebron
Barcelona, Spain
Actively Recruiting
90
Hospital de Cruces
Bilbao, Spain
Actively Recruiting
91
Complejo Hospitalario de Jaen
Jaén, Spain
Actively Recruiting
92
H. Monteprincipe
Madrid, Spain
Actively Recruiting
93
Hospital 12 de Octubre
Madrid, Spain
Actively Recruiting
94
H Central de Asturias
Oviedo, Spain
Actively Recruiting
95
H. C. U. de Salamanca
Salamanca, Spain
Actively Recruiting
96
H. de Donostia Ntra. Sra. de Aranzazu
San Sebastián, Spain
Actively Recruiting
97
H. General de Galicia
Santiago de Compostela, Spain
Actively Recruiting
98
Hospital Virgen del Rocio
Seville, Spain
Actively Recruiting
99
Carlos Haya
Valencia, Spain
Actively Recruiting
100
Hospital Infantil La Fe
Valencia, Spain
Actively Recruiting
101
H Clinico-Universitario
Zaragoza, Spain
Actively Recruiting
102
Queen Silvia's Children's Hospital
Göteburg, Sweden
Actively Recruiting
103
Childrens Hospital Linkoping
Linköping, Sweden
Actively Recruiting
104
University Children's Hospital
Geneva, Switzerland
Actively Recruiting
105
CHUV
Lausanne, Switzerland
Actively Recruiting
106
Aberdeen: Royal Aberdeen Children's Hospital
Aberdeen, United Kingdom
Actively Recruiting
107
Royal Belfast Hospital for Sick Children
Belfast, United Kingdom
Actively Recruiting
108
Birmingham Children's Hospital
Birmingham, United Kingdom
Actively Recruiting
109
Bristol Royal Hospital for Children
Bristol, United Kingdom
Actively Recruiting
110
Addenbrooke's NHS Trust
Cambridge, United Kingdom
Actively Recruiting
111
Llandough Hospital
Cardiff, United Kingdom
Actively Recruiting
112
Edinburgh Royal Hospital for Sick Children
Edinburgh, United Kingdom
Actively Recruiting
113
Glasgow Royal Hospital for Sick Children
Glasgow, United Kingdom
Actively Recruiting
114
Leeds: St James's University Hospital
Leeds, United Kingdom
Actively Recruiting
115
Leicester Royal Infirmary
Leicester, United Kingdom
Actively Recruiting
116
Liverpool: Alder Hey Children's Hospital
Liverpool, United Kingdom
Actively Recruiting
117
Great Ormond Street Hospital
London, United Kingdom
Actively Recruiting
118
St Bartholomew's Hospital
London, United Kingdom
Actively Recruiting
119
UCLH University College London Hospital
London, United Kingdom
Actively Recruiting
120
Royal Manchester Children's Hospital
Manchester, United Kingdom
Actively Recruiting
121
Newcastle: Royal Victoria Infirmary
Newcastle, United Kingdom
Actively Recruiting
122
Nottingham: Queen's Medical Centre
Nottingham, United Kingdom
Actively Recruiting
123
Oxford: John Radcliffe Hospital
Oxford, United Kingdom
Actively Recruiting
124
Sheffield Children's Hospital
Sheffield, United Kingdom
Actively Recruiting
125
Southampton General Hospital
Southhampton, United Kingdom
Actively Recruiting
126
Royal Marsden Hospital
Sutton, United Kingdom
Actively Recruiting
Research Team
R
Ruth L Ladenstein, MD, MBA, cPM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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