Back to resultsQuadruple Immunotherapy for Neuroblastoma
Primary Purpose
Neuroblastoma Recurrent
Status
Recruiting
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Natural killer cell
Dinutuximab beta
Interleukin-2
Granulocyte-Macrophage Colony-Stimulating Factor
Spironolactone
Sponsored by
About this trial
This is an interventional treatment trial for Neuroblastoma Recurrent
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
Sites / Locations
- Hong Kong Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Quadruple immunotherapy
Outcomes
Primary Outcome Measures
Proportion of patients who have objective response in the tumor
Objective response = complete response + partial response + minor response + stable disease
Secondary Outcome Measures
Overall survival at 1 year
From the date of treatment start until the date of death from any cause, assessed up to 1 year
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
Proportion of patients who have tumor relapse
relapse = reappearance of tumor after complete response
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)
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
Full Information
NCT ID
NCT05754684
First Posted
November 18, 2022
Last Updated
February 22, 2023
Sponsor
Hong Kong Children's Hospital
Collaborators
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05754684
Brief Title
Quadruple Immunotherapy for Neuroblastoma
Official Title
Quadruple Immunotherapy for Paediatric Patients With Relapsed or Refractory Neuroblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Children's Hospital
Collaborators
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma Recurrent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Quadruple immunotherapy
Intervention Type
Biological
Intervention Name(s)
Natural killer cell
Other Intervention Name(s)
NK cell
Intervention Description
Natural killer cells isolated from HLA-haploidentical relative donor
Intervention Type
Drug
Intervention Name(s)
Dinutuximab beta
Other Intervention Name(s)
Ch14.18
Intervention Description
Dinutuximab beta iv for 5 days
Intervention Type
Drug
Intervention Name(s)
Interleukin-2
Other Intervention Name(s)
Aldesleukin
Intervention Description
Interleukin-2 sc alternate day for 6 doses
Intervention Type
Drug
Intervention Name(s)
Granulocyte-Macrophage Colony-Stimulating Factor
Other Intervention Name(s)
Sargramostim
Intervention Description
Granulocyte-macrophage colony-stimulating factor sc daily till ANC >2,000/mm3
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Other Intervention Name(s)
Aldactone
Intervention Description
Spironolactone po three time daily
Primary Outcome Measure Information:
Title
Proportion of patients who have objective response in the tumor
Description
Objective response = complete response + partial response + minor response + stable disease
Time Frame
1-2 months
Secondary Outcome Measure Information:
Title
Overall survival at 1 year
Description
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
Title
Progression-free survival
Description
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
Title
Proportion of patients who have tumor relapse
Description
relapse = reappearance of tumor after complete response
Time Frame
up to 1 year
Title
Number of patients who experience adverse events
Description
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
Title
Percentage of donor NK cells
Description
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
Time Frame
up to 1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Cheuk
Phone
852-35136049
Email
cheukkld@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Cheuk
Organizational Affiliation
Hong Kong Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong Kong Children's Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Cheuk
Phone
851-35136049
Email
cheukkld@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Quadruple Immunotherapy for Neuroblastoma
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