Informations générales (source: ClinicalTrials.gov)

NCT01704716 En recrutement IDF
High Risk Neuroblastoma Study 1 of SIOP-Europe (SIOPEN)
Interventional
  • Neuroblastome
Phase 3
St. Anna Kinderkrebsforschung (Voir sur ClinicalTrials)
février 2002
septembre 2026
29 juin 2024
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.
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Armand Trousseau-La Roche Guyon En recrutement IDF Contact (sur clinicalTrials)
CLCC INSTITUT CURIE En recrutement IDF Contact (sur clinicalTrials)
CLCC INSTITUT GUSTAVE ROUSSY En recrutement IDF Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Oscar Lambret de Lille - Lille - France En recrutement Contact (sur clinicalTrials)
CHR de Nantes - Nantes - France En recrutement Contact (sur clinicalTrials)
CHR Pellegrin - Le Pellerin - France En recrutement Contact (sur clinicalTrials)
CHU de Grenoble - Grenoble - France En recrutement Contact (sur clinicalTrials)
CHU-Saint Etienne - Saint Etienne - France En recrutement Contact (sur clinicalTrials)
Hôpital American Memorial Hospital - Reims - France En recrutement Contact (sur clinicalTrials)
Hôpital de Hautepierre - Strasbourg - France En recrutement Contact (sur clinicalTrials)
Hôpital D'Enfants de Toulouse - Toulouse - France En recrutement Contact (sur clinicalTrials)
Hopital d'Enfants Dijon - Dijon - France En recrutement Contact (sur clinicalTrials)
Hopitaux de Marseille La Timone - Marseille - France En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- • Established diagnosis of neuroblastoma according to the International
Neuroblastoma Staging System (INSS).

- Age below 21 years.

- High risk neuroblastoma defined as either:

1. INSS stage 2, 3, 4, and 4s with MYCN amplification, or

2. INSS stage 4 without MYCN amplification aged > 12 months at diagnosis

- Patients who have received no previous chemotherapy except for one cycle of
etoposide and carboplatin (VP16/Carbo). In this situation patients will receive
Rapid COJEC induction and the first Rapid COJEC cycle may be replaced by the
first cycle VP16/Carbo (etoposide / carboplatin).

- Written informed consent, including agreement of parents or legal guardian for
minors, to enter a randomised study if the criteria for randomisation are met.

- Tumour cell material available for determination of biological prognostic
factors.

- Females of childbearing potential must have a negative pregnancy test. Patients
of childbearing potential must agree to use an effective birth control method.
Female patients who are lactating must agree to stop breast-feeding.

- Registration of all eligibility criteria with the data centre within 6 weeks
from diagnosis.

- Provisional follow up of 5 years.

- National and local ethical committee approval.



Any negative answer concerning the inclusion criteria of the study

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