Health TrialsbyHealthPanel

Quadruple Immunotherapy for Neuroblastoma

ConditionNeuroblastoma Recurrent
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorHong Kong Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Natural killer cell

    Biological/Vaccine

    Natural killer cells isolated from HLA-haploidentical relative donor

  • Dinutuximab beta

    Drug

    Dinutuximab beta iv for 5 days

  • Interleukin-2

    Drug

    Interleukin-2 sc alternate day for 6 doses

  • Granulocyte-Macrophage Colony-Stimulating Factor

    Drug

    Granulocyte-macrophage colony-stimulating factor sc daily till ANC \>2,000/mm3

  • Spironolactone

    Drug

    Spironolactone po three time daily

  • Naxitamab

    Drug

    Naxitamab iv for 4 days (as alternative for dinutuximab)

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients who have objective response in the tumor

Objective response = complete response + partial response + minor response + stable disease

Time frame
1-2 months

Secondary outcomes

1

Overall survival at 1 year

From the date of treatment start until the date of death from any cause, assessed up to 1 year

Time frame
up to 1 year
2

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

Time frame
up to 1 year
3

Proportion of patients who have tumor relapse

relapse = reappearance of tumor after complete response

Time frame
up to 1 year
4

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)

Time frame
up to 1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hong Kong Children's Hospital

Lead sponsor

The University of Hong Kong

Collaborator

Source ClinicalTrials.gov
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