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Trial Title:
Quadruple Immunotherapy for Neuroblastoma
NCT ID:
NCT05754684
Condition:
Neuroblastoma Recurrent
Conditions: Official terms:
Neuroblastoma
Aldesleukin
Interleukin-2
Molgramostim
Dinutuximab
Spironolactone
Sargramostim
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Natural killer cell
Description:
Natural killer cells isolated from HLA-haploidentical relative donor
Arm group label:
Intervention
Other name:
NK cell
Intervention type:
Drug
Intervention name:
Dinutuximab beta
Description:
Dinutuximab beta iv for 5 days
Arm group label:
Intervention
Other name:
Ch14.18
Intervention type:
Drug
Intervention name:
Interleukin-2
Description:
Interleukin-2 sc alternate day for 6 doses
Arm group label:
Intervention
Other name:
Aldesleukin
Intervention type:
Drug
Intervention name:
Granulocyte-Macrophage Colony-Stimulating Factor
Description:
Granulocyte-macrophage colony-stimulating factor sc daily till ANC >2,000/mm3
Arm group label:
Intervention
Other name:
Sargramostim
Intervention type:
Drug
Intervention name:
Spironolactone
Description:
Spironolactone po three time daily
Arm group label:
Intervention
Other name:
Aldactone
Intervention type:
Drug
Intervention name:
Naxitamab
Description:
Naxitamab iv for 4 days (as alternative for dinutuximab)
Arm group label:
Intervention
Other name:
hu3F8
Summary:
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.
Criteria for 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
Gender:
All
Minimum age:
N/A
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hong Kong Children's Hospital
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Daniel Cheuk
Phone:
852-35136049
Email:
cheukkld@gmail.com
Start date:
January 1, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Hong Kong Children's Hospital
Agency class:
Other
Collaborator:
Agency:
The University of Hong Kong
Agency class:
Other
Source:
Hong Kong Children's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05754684
