Study to optimise the treatment for high risk neuroblastoma patients

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 2230

Inclusion Criteria

•Established diagnosis of neuroblastoma according to the International Neuroblastoma Diagnostic Criteria (INSS).
•Age below 21 years.
•High Risk Neuroblastoma, defined as either:
a)INSS stages 2, 3, 4 or 4s with MYCN amplification, or
b)INSS stage 4 without MYCN amplification aged =12 months at diagnosis
•Patients who have received no previous chemotherapy except for 1 cycle of etoposide and carboplatin (VP/Carbo). In this situation the first COJEC cycle may be replaced by the first cycle of VP/Carbo. Infants awaiting MYCN analysis prior to registration may receive the first cycle of COJEC or etoposide / carboplatin. Any patient who has had rapid COJEC induction chemotherapy according to the protocol can enter the trial providing they are no more than 6 weeks from diagnosis. Any patient who has had one or more cycles of Rapid COJEC or VP/Carbo will receive Rapid COJEC induction and will not be eligible for the R3 randomisation.
•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.
•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.
R3:
•Diagnosis of neuroblastoma confirmed.
•Stage 4; or Stage 4s with MYCN amplification.
•No prior chemotherapy.
•Written informed consent to participate in R3 randomisation, and for minors an agreement by parents or legal guardian.
•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.
R2:
•All patients must be enrolled on the study and have completed therapy including intensive induction (Rapid COJEC or modified N7) with or without two additional cycles of TVD.
•BuMel MAT (minor modifications for toxicity concerns) are permitted to render a patient eligible for R2 randomisation, even after more than one line of induction treatment. However, patients must be no more than 9 months from the date of starting the first induction chemotherapy after diagnosis to the date of PBSCR.
•Complete re-staging, which shows no evidence of progression, following recovery from major transplant related toxicities.
•Stable WBC above 2 x 109/L (or stable neutrophil count greater than 0.5 x 109/L) in 2 counts taken 48h apart after cessation of G-CSF.
•Written informed consent to participate in R2 randomisation and for minors an agreement by parents or legal guardian.
•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.
•Radiotherapy must be scheduled to stop at least 7 days prior to the start of immunotherapy.
•Immunotherapy (starting with week 1 isotretinoin (13-cis-RA)) must start no later than day 120 post PBSCR.

Are the trial subjects under 18? yes
Number of subjects for this age range: 2200
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age r

Exclusion Criteria

Any negative answer concerning the inclusion criteria of the study, R2 and R3 will render the patient ineligible for the corresponding therapy phase.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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