Quadruple Immunotherapy for Neuroblastoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Natural killer cell, Dinutuximab beta, Interleukin-2, Granulocyte-Macrophage Colony-Stimulating Factor.
- Who it may be relevant to
- Registry conditions: Neuroblastoma Recurrent. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Quadruple Immunotherapy for Paediatric Patients With Relapsed or Refractory Neuroblastoma
Overview
This is a single-arm clinical trial to evaluate the efficacy and safety of quadruple immunotherapy with natural killer (NK) cells, anti-GD2 antibody, cytokines (interleukin-2 (IL-2) and granulocyte-macrophage colony stimulating factor (GM-CSF)) and retinoid X receptor gamma (RXRg) agonist spironolactone for paediatric patients with relapsed or refractory neuroblastoma.
Detailed description
Included patients will receive intravenous infusion of donor NK cells on day 0, and anti-GD2 antibody (dinutuximab) on day -6 to day -2. IL-2 will be given subcutaneously on day -1, day +1, day +3, day +5, day +7, and day +9. Subcutaneous injection of GM-CSF will be started on day 0, given daily till neutrophil count \>1000/mm3. Spironolactone will be started orally on day -1, given three times daily till cessation of GM-CSF.
Alternative anti-GD2 antibody (Naxitamab) can be used instead of dinutuximab, to be given on day -5, day -3, day +1 and day +3.
Interventions
- Biological Natural killer cell
Natural killer cells isolated from HLA-haploidentical relative donor - Drug Dinutuximab beta
Dinutuximab beta iv for 5 days - Drug Interleukin-2
Interleukin-2 sc alternate day for 6 doses - Drug Granulocyte-Macrophage Colony-Stimulating Factor
Granulocyte-macrophage colony-stimulating factor sc daily till ANC \>2,000/mm3 - Drug Spironolactone
Spironolactone po three time daily - Drug Naxitamab
Naxitamab iv for 4 days (as alternative for dinutuximab)
Primary outcome measures
- Proportion of patients who have objective response in the tumor [Time frame: 1-2 months]
Secondary outcome measures (5)
- Overall survival at 1 year [Time frame: up to 1 year]
- Progression-free survival [Time frame: up to 1 year]
- Proportion of patients who have tumor relapse [Time frame: up to 1 year]
- Number of patients who experience adverse events [Time frame: up to 1 month]
- Percentage of donor NK cells [Time frame: up to 1 year]
Eligibility criteria
Inclusion criteria
- relapsed or refractory neuroblastoma
- Adequate organ function: creatinine clearance ≥40 ml/min/1.73m2, total bilirubin ≤3 times upper limit of normal and ALT ≤500 IU/L, left ventricular shortening fraction ≥25%, and oxygen saturation ≥92% in room air
- Karnofsky or Lansky performance status score ≥50
- Has an appropriate HLA-haploidentical NK-cell donor available
Exclusion criteria
- Pregnant or lactating woman
- HIV infection
- Patients for whom conventional treatment is deemed more appropriate
- Patients who are unlikely to benefit, e.g., terminal malignancy with life expectancy <1 month
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Hong Kong Children's Hospital — Hong Kong
Identifiers
NCT: NCT05754684 · HKCH-REC-2021-007