Neuroblastoma Recurrent Clinical Trial
Official title:
Quadruple Immunotherapy for Paediatric Patients With Relapsed or Refractory Neuroblastoma
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.
| Status | Recruiting |
| Enrollment | 29 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Hong Kong Children's Hospital | Hong Kong |
| Lead Sponsor | Collaborator |
|---|---|
| Hong Kong Children's Hospital | The University of Hong Kong |
Hong Kong,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients who have objective response in the tumor | Objective response = complete response + partial response + minor response + stable disease | 1-2 months | |
| Secondary | Overall survival at 1 year | From the date of treatment start until the date of death from any cause, assessed up to 1 year | up to 1 year | |
| Secondary | Progression-free survival | From date of treatment start until the date of first documented progression or the date of death from any cause, whichever comes first, assessed up to 1 year | up to 1 year | |
| Secondary | Proportion of patients who have tumor relapse | relapse = reappearance of tumor after complete response | up to 1 year | |
| Secondary | Number of patients who experience adverse events | Adverse events are graded according to Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5 (CTCAEv5) | up to 1 month | |
| Secondary | Percentage of donor NK cells | Percentage of donor natural killer cells in the recipient's blood will be evaluated weekly from the date of NK cell infusion for 4 weeks, then every 2 weeks till donor NK cells are undetectable | up to 1 year |
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