Revisions of the international criteria for neuroblastoma diagnosis, staging, and response to treatment.
G M Brodeur, J Pritchard, F Berthold...
https://pubmed.ncbi.nlm.nih.gov/8336186Actively Recruiting
Phase 1
Phase 2
Age: 1Year +
All Genders
ID07334301
A Multi-Arm, Multi-Stage Platform Trial For Relapsed Neuroblastoma
Led by University of Birmingham · Updated on 2026-01-12
160
Participants Needed
23
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Relapsed neuroblastoma is a common and serious childhood cancer that is difficult to treat, especially in high-risk cases where the disease returns after initial treatment or does not respond to standard therapies. This trial aims to improve survival for children aged 1 year and older with relapsed neuroblastoma by testing new combinations of treatments. It is an international, open-label, randomized phase I/II study designed to develop and evaluate these new therapies while also studying the biology of the disease using biomarker samples. Participants will be randomly assigned to one of two main treatment groups or enrolled in smaller dose confirmation groups testing new drug combinations. The current main treatments include combinations of dinutuximab beta, irinotecan, temozolomide, and bevacizumab given in 12 cycles every three weeks. Additional experimental groups may receive different combinations of these drugs. The trial includes a translational sub-study collecting tumor, blood, and bone marrow samples to better understand neuroblastoma and improve targeted therapies. During the study, patients will receive their assigned treatments over multiple cycles and be closely monitored for safety, treatment response, and quality of life. Researchers will perform various assessments including imaging scans, laboratory tests, and questionnaires to measure progression-free survival, side effects, and overall clinical benefit. Follow-up will continue up to five years after treatment to assess long-term outcomes and collect further data on patient health and disease progression.
CONDITIONS
Brief Title
A Multi-Arm, Platform Trial For Relapsed Neuroblastoma
Who Can Participate
Age: 1Year +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed neuroblastoma as defined by the International Neuroblastoma Staging System
- High-risk relapsed or progressed neuroblastoma
- Measurable or evaluable disease by imaging or MIBG scan (bone marrow-only disease is not eligible)
- Age 1 year or older
- Signed informed consent from participant, parent, or guardian
- Performance status Lansky (≤12 years) or Karnofsky (>12 years) of 50% or higher
- Life expectancy of at least 12 weeks
- Adequate bone marrow function with platelets ≥ 50 x 10^9/L, ANC ≥ 0.5 x 10^9/L, hemoglobin > 8 g/dL
- Adequate renal function with no significant proteinuria and creatinine ≤ 1.5 times upper limit for age
- Adequate liver function with AST/ALT and bilirubin within specified limits
- No active uncontrolled coagulopathy; stable anticoagulation allowed
- Blood pressure below 95th percentile for age and sex (≤150/90 mmHg for ≥18 years), antihypertensive medication allowed
- For Tier 2: more than one relapse or ineligible for Tier 1
- Previous treatments with bevacizumab, anti-GD2 antibodies with chemotherapy, or temozolomide with irinotecan allowed with investigator approval
You will not qualify if you...
- Known allergy to any study drug or components including Chinese hamster ovary products and humanized antibodies
- Severe hypersensitivity reactions to anti-GD2 antibodies (grade 4 or higher)
- Significant neurological toxicity or uncontrolled seizures
- Prior severe arterial thrombo-embolic events or ongoing events
- History or current pneumonitis requiring steroids
- Allergic to all treatments for Pneumocystis jirovecii pneumonia
- Uncontrolled infections
- Incomplete recovery from prior surgery with serious complications
- Recent surgeries or biopsies within specified timeframes prior to starting treatment
- Recent chemotherapy, anti-GD2 therapy, or certain radiotherapies within specified washout periods
- Bleeding metastases or recent severe bleeding events
- Use of enzyme-inducing anticonvulsants within 72 hours before treatment
- Conditions increasing risk of bevacizumab toxicity such as bleeding disorders or recent gastrointestinal complications
- Intolerance to galactose, fructose, or related absorption defects
- Pregnant or breastfeeding participants
- Recent live vaccines within 28 days prior to enrollment
- Uncontrolled medical conditions posing additional risk
- More than one relapse after starting high-risk therapy (Tier 1 exclusion)
- Prior bevacizumab for relapsed neuroblastoma (Tier 1 exclusion)
- Prior chemo-immunotherapy anti-GD2 treatment for relapsed neuroblastoma with disease progression (Tier 1 exclusion)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 12 cycles, each cycle lasting 21 days
Participants receive treatment with one of the study drug combinations for relapsed neuroblastoma.
Up to 12 treatment cycles with visits at the start of each cycle
Follow-up
Duration - Up to 60 months
Participants are monitored for progression-free survival, overall survival, and side effects after completing treatment.
Regular visits for assessments during follow-up period
Trial Site Locations
Total: 23 locations
1
Sydney Children's Hospital (SCH)
Sydney, Australia
Not Yet Recruiting
2
St. Anna Children´s Hospital
Vienna, Austria
Not Yet Recruiting
3
Cliniques Universitaires Saint-Luc (CUSL)
Brussels, Belgium
Not Yet Recruiting
4
Starship Children's Hospital (SSH)
Auckland, New Zealand
Not Yet Recruiting
5
Royal Aberdeen Children's Hospital
Aberdeen, United Kingdom
Actively Recruiting
6
Royal Belfast Hospital for Sick Children
Belfast, United Kingdom
Not Yet Recruiting
7
Birmingham Children's Hospital
Birmingham, United Kingdom
Actively Recruiting
8
Bristol Royal Hospital for Children
Bristol, United Kingdom
Actively Recruiting
9
Addenbrookes Hospital
Cambridge, United Kingdom
Actively Recruiting
10
Children's Hospital for Wales
Cardiff, United Kingdom
Actively Recruiting
11
Royal Hospital for Sick Children
Edinburgh, United Kingdom
Not Yet Recruiting
12
Royal Hospital for Children
Glasgow, United Kingdom
Not Yet Recruiting
13
Leeds General Infirmary
Leeds, United Kingdom
Actively Recruiting
14
Alder Hey Hospital
Liverpool, United Kingdom
Actively Recruiting
15
Great Ormond Street Hospital
London, United Kingdom
Actively Recruiting
16
University College London Hospital
London, United Kingdom
Not Yet Recruiting
17
Royal Manchester Children's Hospital
Manchester, United Kingdom
Actively Recruiting
18
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Actively Recruiting
19
Nottingham Children's Hospital
Nottingham, United Kingdom
Not Yet Recruiting
20
John Radcliffe Hospital
Oxford, United Kingdom
Not Yet Recruiting
21
Sheffield Children's Hospital
Sheffield, United Kingdom
Actively Recruiting
22
Southampton General Hospital
Southampton, United Kingdom
Actively Recruiting
23
Royal Marsden Hospital
Sutton, United Kingdom
Actively Recruiting
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Research Team
T
Trial Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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