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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01704716
Registration number
NCT01704716
Ethics application status
Date submitted
5/10/2012
Date registered
11/10/2012
Date last updated
23/10/2020
Titles & IDs
Public title
High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)
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Scientific title
High Risk Neuroblastoma Study 1 of SIOP-Europe (SIOPEN)
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Secondary ID [1]
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HR-NBL-1.8 / SIOPEN
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neuroblastoma
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Condition category
Condition code
Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Children's - Other
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Vincristine
Treatment: Drugs - Aldesleukin
Treatment: Drugs - ch14.18/CHO
Treatment: Drugs - Carboplatin
Treatment: Drugs - Etoposide
Treatment: Drugs - Cisplatin
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - G-CSF
Treatment: Drugs - Busulfan
Treatment: Drugs - Melphalan
Experimental: R0: COJEC plus G-CSF - Patients randomised to G-CSF during induction treatment (Rapid COJEC) received a single daily subcutaneous injection of 5 microgram/kg/day G-CSF (filgrastim) beginning 24 hours after the last chemotherapy dose.
Active Comparator: R0: COJEC - Induction treatment (COJEC) without filgrastim Patients randomised to Rapid COJEC alone will receive induction Treatment without G-CSF
Active Comparator: R1: BuMel MAT - The BuMel MAT regimen consists of oral administration of busulphan and the short i.v. infusion of melphalan.
In July 2007 (amendment 3) oral busulfan was changed to i.v. Busulfan (Busilvex)
Experimental: R1: CEM MAT - The CEM MAT regimen uses three drugs: the dose of Carboplatin must be based on renal function with a target area under the concentration versus time curve (AUC) of 16.4 mg/ml.min, etoposide 350 mg/m2/course and melphalan 210 mg/m2/course
Active Comparator: R2: ch14.18/CHO - ch14.18/CHO is given at a dose of 20 mg/m2/day over five days every four weeks for five courses
Experimental: R2: ch14.18/CHO plus Aldesleukin - Patients randomised to receive ch14.18/CHO plus Aldesleukin
Active Comparator: R3: COJEC Induction - Rapid COJEC induction treatment is applied over ten weeks; three different courses are given every ten days:
Course A (given on days 0 and 40): vincristine, carboplatin, and etoposide Course B (given on days 10, 30, 50, and 70): vincristine and cisplatin Course C (given on days 20 and 60): vincristine, etoposide, and cyclophosphamide
Experimental: R3: Modified N7 - The modified N7 induction is a dose intense induction chemotherapy regimen including two putatively non cross-resistent drug combinations: high-dose cyclophosphamide plus doxorubicin/vincristine (CAV) and high-dose cisplatin/etoposide (P/E).
Active Comparator: R4: cnt inf ch14.18/CHO - ch14.18/CHO is given as continuous Infusion over 10 days at a cumulative dose of 100mg/m2. Patients receive 5 cycles of ch14.18/CHO
Experimental: R4: cnt inf ch14.18/CHO plus Aldesleukin - ch14.18/CHO is given as continuous Infusion over 10 days at a cumulative dose of 100mg/m2. Patients receive 5 cycles of ch14.18/CHO.
In addition, Aldesleukin is given at a dose of 3 x 10e6 on days 1 to 5 and on days 9, 11, 13, 15, and 17 during ch14.18/CHO infusion
Treatment: Drugs: Vincristine
given during Rapid COJEC and modified N7 therapy
Treatment: Drugs: Aldesleukin
Aldesleukin is given during MRD Treatment for patients randomised to the arm with IL-2
Treatment: Drugs: ch14.18/CHO
ch14.18/CHO antibody is given during MRD treatment
Treatment: Drugs: Carboplatin
Carboplatin is given during induction Treatment (R3 randomisation: Rapid COJEC arm)
Treatment: Drugs: Etoposide
Etoposide is given during Induction Treatment (both R3 randomisation arms)
Treatment: Drugs: Cisplatin
Cisplatin is given during Induction Treatment (both R3 randomisation arms)
Treatment: Drugs: Cyclophosphamide
Cyclophosphamid is given during Induction Treatment (both R3 randomisation arms)
Treatment: Drugs: Doxorubicin
Doxorubicin is given during Induction Treatment (R3 arm modified N7)
Treatment: Drugs: G-CSF
G-CSF is given during Induction Treatment
Treatment: Drugs: Busulfan
In case i.v. busulfan is not available, the use of oral busulfan is permitted, although not recommended.
Treatment: Drugs: Melphalan
Melphalan is given during MAT treatment
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event Free Survival (R1: MAT therapy)
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Assessment method [1]
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The primary endpoint was the event free survival (EFS) calculated from the date of the first R1 randomisation. The following was considered as event:
disease progression or relapse
death from any cause
second neoplasm
Patients lost to follow up without event were considered at the date of their last follow up evaluation.
R1 has been closed in October 2010 following the results of R1 randomisation showing significant superiority for myeloablative therapy (MAT) with busulfan and melphalan (BuMel) in patients with high risk neuroblastoma over MAT with continuous infusion of carboplatin, etoposide and melphalan (CEM). BuMel is now the standard MAT.
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Timepoint [1]
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Up to three years
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Primary outcome [2]
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Event Free Survival (immunotherapy)
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Assessment method [2]
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R2 randomisation comparing immunotherapy with ch14.18/CHO and 13-cis retinoic acid versus 13-cis retinoic acid alone was activated in November 2006. It was amended in July 2009 and compares immunotherapy with anti GD2 antibody ch14.18/CHO with or without aldesleukin (IL-2). Immunotherapy randomisation has been amended in 2014 (R4 randomisation). The ch14.18/CHO antibody is given as continuous Infusion and the randomisation has lasted until the necessary number of patients for R3 randomisation was reached
The primary endpoint is 3-year event free survival calculated from the date of the second randomisation. The following will be considered as events:
disease progression or relapse
death from any cause
second neoplasm
Patients lost to follow up without event will be censored at the date of their last follow-up evaluation.
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Timepoint [2]
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Up to three years
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Primary outcome [3]
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Complete metastatic response (R3: Induction therapy)
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Assessment method [3]
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R3 randomisation compares two different induction therapy regimen, Rapid COJEC and modified N7.
Complete metastatic response after induction is defined as:
no skeletal uptake on mIBG
Negative bone marrow aspirates (by cytomorphology) and trephines
Absence of other metastatic sites
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Timepoint [3]
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Up to 95 days
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Primary outcome [4]
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Event free survival (R3: Induction therapy)
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Assessment method [4]
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R3 randomisation compares two different induction therapy regimen, Rapid COJEC and modified N7.
The primary endpoint is event free survival calculated from the date of the R3-randomisation. The following will be calculated as events:
disease progression or relapse
death from any cause
second neoplasm
Patients lost to follow up without event will be censored at the date of their last follow up evaluation
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Timepoint [4]
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Up to three years
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Eligibility
Key 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.
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Minimum age
1
Month
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Any negative answer concerning the inclusion criteria of the study
-
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2002
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2026
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Actual
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Sample size
Target
3300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Women and Children´s Hospital - Adelaide
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Lady Cilento Children´s Hospital - Brisbane
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John Hunter Children's Hospital - Newcastle
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Royal Children's Hospital Melbourne - Parkville
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Sydney Children's Hospital - Sydney
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Children´s Hospital Westmead - Westmead
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- Adelaide
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- Brisbane
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- Newcastle
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- Parkville
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- Sydney
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Recruitment postcode(s) [6]
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- Westmead
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Recruitment outside Australia
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Austria
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Austra
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Austria
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Graz
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Nottingham
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United Kingdom
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Oxford
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Country [109]
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United Kingdom
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Sheffield
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United Kingdom
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Southhampton
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Other
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Name
St. Anna Kinderkrebsforschung
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/ct2/show/NCT01704716
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Ruth L Ladenstein, MD, MBA, cPM
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St. Anna Kinderkrebsforschung
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Contact person for public queries
Name
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Ruth L Ladenstein, MD, MBA, cPM
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Phone
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0043140470
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01704716
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