Phase II Study of Monoclonal Antibody ch14.18/CHO Continuous Infusion in Patients With Primary Refractory or Relapsed Neuroblastoma

NCT02743429 | Unknown Phase 2

• 2 other identifiers: APN311-3042014-000588-42
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

Brief Summary

In this trial, monoclonal anti-Disialoganglioside GD2 (GD2) antibody ch14.18/CHO will be assessed for the treatment of patients with relapsed or refractory neuroblastoma. The antibody is used as a single agent applied in a new treatment schedule associated with less side effects.

Conditions

Neuroblastoma

Keywords

ch14.18/CHO; neuroblastoma; long term infusion

Outcome Measures

Primary Outcomes (1)

• Anti-tumour activity of ch14.18/CHO continuous infusion

  The response rate in patients with measurable/evaluable disease (skeletal lesions, soft tissue lesions, lymph nodes and/or primary tumour site and bone marrow) as measured by Metaiodobenzylguanidine scan (MIBG), Computed tomography (CT), Magnetic Resonance Imaging (MRI) and/or immunocytology at the end of the study.

  2 years

Secondary Outcomes (14)

• Progression-Free Survival

  5 years

• Safety and tolerability

  2 years

• Immunogenicity

  2 years

• Immunophenotyping

  2 years

• Antibody dependent cellular cytotoxicity (ADCC)

  2 years

Study Arms (1)

Long term infusion of ch14.18/CHO

EXPERIMENTAL

10 day continuous Infusion of ch14.18/CHO.

Drug: dinutuximab beta

Interventions

dinutuximab beta DRUG

Up to 5 cycles of continuous infusion of ch14.18/CHO is administered at a dose of 10 mg/m2/day over 10 days (total dose 100 mg/m2/cycle). Cycle duration: 35-days.

Long term infusion of ch14.18/CHO

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ≥ 12 months and ≤ 21 years of age at the time of study entry
• Diagnosis of neuroblastoma according to the INSS criteria
• Tumour burden controlled by conventional therapy (except patients with early minimal bone marrow relapse) fulfilling one of the following criteria:
• \- Primary refractory patients with stage 4 disease
• Relapse after primary stage 4 disease
• Disseminated relapse after primary localized neuroblastoma.
• Measurable and/or evaluable disease in any of the following sites (skeletal lesions, soft tissue lesions, lymph nodes and/or primary tumour site and/or bone marrow) as measured by mIBG scan, CT, MRI and/or immunocytology
• Life expectancy of at least 12 weeks.
• Performance status greater or equal to 70% (Lansky Score or Karnofsky)
• Consent to the placement of a central venous line, if one has not already been placed
• Off any standard or experimental treatment for at least two weeks prior to start of immunotherapy (Day 1 of cycle 1) and fully recovered from the short-term major toxic effects
• No immediate requirements for palliative chemotherapy, radiotherapy or surgery
• At least 2 weeks from any tumour surgery and fully recovered from any post-surgical complications
• HIV sero-negative
• Neither active nor chronic-replicative Hepatitis B infection

You may not qualify if:

• ADA positivity due to previous treatment with an anti-GD2 antibody (e.g. ch14.18/SP2/0, ch14.18/CHO).
• Previous treatment with ch14.18/CHO in this study.
• e) Requirement, or likely requirement, for corticosteroids or other immunosuppressive drugs.
• f) Concurrent treatment with any non-trial anticancer therapies. g) Patients with hypersensitivity against one component of the investigational product or against mouse proteins.
• h) Female patients of childbearing potential if pregnant, nursing, or not using effective contraception during the treatment period, as the potential effects of ch14.18 on the fetus have not been determined.

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Children's Cancer Research Institute, Austria: collaborator

Study Sites (2)

St. Anna Kinderkrebsforschung e.V. CHILDREN'S CANCER RESEARCH INSTITUTE

Vienna, 1090, Austria

Location

University Medicine Greifswald

Greifswald, 17475, Germany

Location

Related Publications (1)

• Lode HN, Ehlert K, Huber S, Troschke-Meurer S, Siebert N, Zumpe M, Loibner H, Ladenstein R. Long-term, continuous infusion of single-agent dinutuximab beta for relapsed/refractory neuroblastoma: an open-label, single-arm, Phase 2 study. Br J Cancer. 2023 Nov;129(11):1780-1786. doi: 10.1038/s41416-023-02457-x. Epub 2023 Oct 10.

  PMID: 37813959 DERIVED

MeSH Terms

Conditions

Neuroblastoma

Interventions

dinutuximab

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Holger Lode, Professor

  University Medicine Greifswald

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: April 19, 2016
• Study Start: March 27, 2015
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: October 4, 2021

Record last verified: 2021-10

Locations

DE (1); AU (1)