Quadruple Immunotherapy for Neuroblastoma

February 22, 2023 updated by: Cheuk Ka Leung Daniel, Hong Kong Children's Hospital

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Hong Kong Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Quadruple immunotherapy
Natural killer cells isolated from HLA-haploidentical relative donor
Other Names:
  • NK cell
Dinutuximab beta iv for 5 days
Other Names:
  • Ch14.18
Interleukin-2 sc alternate day for 6 doses
Other Names:
  • Aldesleukin
Granulocyte-macrophage colony-stimulating factor sc daily till ANC >2,000/mm3
Other Names:
  • Sargramostim
Spironolactone po three time daily
Other Names:
  • Aldactone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who have objective response in the tumor
Time Frame: 1-2 months
Objective response = complete response + partial response + minor response + stable disease
1-2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival at 1 year
Time Frame: up to 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
Progression-free survival
Time Frame: up to 1 year
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
Proportion of patients who have tumor relapse
Time Frame: up to 1 year
relapse = reappearance of tumor after complete response
up to 1 year
Number of patients who experience adverse events
Time Frame: up to 1 month
Adverse events are graded according to Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5 (CTCAEv5)
up to 1 month
Percentage of donor NK cells
Time Frame: up to 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Daniel Cheuk, Hong Kong Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

November 18, 2022

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Estimate)

March 6, 2023

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact re[email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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