High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

Summary

This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma.

Conditions

• High-Risk Neuroblastoma
• Patient With Insufficient Response Chemoimmunotherapy

Interventions

DRUG

Vincristine

1.5 mg/m2 (max dose 2 mg)

DRUG

Carboplatin

750 mg/m2

DRUG

Etoposide

175 mg/m2

DRUG

Vindesine

3 mg/m2/day (max dose 6 mg)

DRUG

Dacarbazine

200 mg/m2/day

DRUG

Ifosfamide

1500 mg/m2/day

DRUG

Doxorubicin

30 mg/m2/dose

DRUG

Busulfan

\< 9kg: 1.0 mg/kg/dose 9 kg to \< 16 kg : 1.2 mg/kg/dose 16 kg to 23 kg : 1.1 mg/kg/dose \>23 kg to 34 kg: 0.95 mg/kg/dose \>34 kg: 0.8 mg/kg/dose Infusion IV over 2 hours Administration every 6 hours for a total of 16 doses

DRUG

Melphalan

140 mg/m2/dose IV short infusion (15'), at least 24 h after the last busulfan dose

DRUG

Thiotepa

300 mg/m2/day over 2 hours

RADIATION

Radiotherapy

21.6 Gy 21.6 Gy + boost de 14.4 Gy

DRUG

Dinutuximab Beta

Patients \>12 kg are dosed based on the BSA: 10 mg/m\^2/day Patients ≤ 12 kg are dosed according to their body weight: 0.33 mg/kg/day

DRUG

Cisplatin

80 mg/m2/24h

DRUG

Temozolomide 100 MG

100 mg/m²/Day

DRUG

Irinotecan

50 mg/m²/jour de J0 à J4

DRUG

Cyclophosphamid

Cyclophosphamide has been demonstrated to have a cytostatic effect in many tumour types. The active metabolites of cyclophosphamide are alkylating agents which transfer alkyl groups to DNA during the process of cell division, thus preventing normal synthesis of DNA.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris

  lead OTHER

Principal Investigators

• Claudia Pasqualini, MD PhD · Gustave roussy, Paris, France

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-05

Primary Completion

2026-11-30

Completion

2032-11-30

Countries

• Australia
• Austria
• Belgium
• Czechia
• Denmark
• Finland
• France
• Germany
• Greece
• Israel
• Italy
• Lithuania
• Netherlands
• Norway
• Slovakia
• Slovenia
• Spain
• Sweden
• Switzerland
• United Kingdom

Study Locations