Neuroblastome à haut risque: étude européenne de la Société Internationale d’Oncologie Pédiatrique

Drug: Vincristine;Drug: Aldesleukin;Drug: ch14.18/CHO;Drug: Carboplatin;Drug: Etoposide;Drug: Cisplatin;Drug: Cyclophosphamide;Drug: Doxorubicin;Drug: G-CSF;Drug: Busulfan;Drug: Melphalan

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.

Exclusion Criteria:

Any negative answer concerning the inclusion criteria of the study

-