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Trial record 11 of 525 for:    "Neuroblastoma"

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

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ClinicalTrials.gov Identifier: NCT02743429
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : November 9, 2016
Sponsor:
Collaborator:
Children's Cancer Research Institute, Austria
Information provided by (Responsible Party):
University Medicine Greifswald

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.

Condition or disease Intervention/treatment Phase
Neuroblastoma Drug: dinutuximab beta Phase 2

Detailed Description:

The Treatment with ch14.18 antibody has demonstrated efficacy in patients with neuroblastoma. However the treatment is associated with an on target side effect, i.e. neuropathic pain. This requires coadministration of intravenous morphine.

In this clinical Trial we will evaluate a less toxic treatment regimen consisting of continuous longterm Infusion (LTI) of ch14.18/CHO administered at a dose of 10 mg/m2/day over 10 days (total dose 100 mg/m2/cycle). Patients may receive up to five 35-day cycles in absence of signs of progression.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Monoclonal Antibody ch14.18/CHO Continuous Infusion in Patients With Primary Refractory or Relapsed Neuroblastoma
Study Start Date : March 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma
Drug Information available for: Dinutuximab

Arm Intervention/treatment
Experimental: Long term infusion of ch14.18/CHO
10 day continuous Infusion of ch14.18/CHO.
Drug: dinutuximab beta

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.





Primary Outcome Measures :
  1. Anti-tumour activity of ch14.18/CHO continuous infusion [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 5 years ]
  2. Safety and tolerability [ Time Frame: 2 years ]
    • Pain intensity and the need for appropriate medication for pain relief
    • Adverse events, vital signs and changes in clinical laboratory assessments

  3. Immunogenicity [ Time Frame: 2 years ]
    Immunogenicity: Anti-Drug Antibody (ADA)

  4. Immunophenotyping [ Time Frame: 2 years ]
    Unit: cells/µl

  5. Antibody dependent cellular cytotoxicity (ADCC) [ Time Frame: 2 years ]
    Unit: %

  6. Complement dependent cytotoxicity (CDC) [ Time Frame: 2 years ]
    Unit: %

  7. Whole Blood Test (WBT) [ Time Frame: 2 years ]
    Unit: %

  8. Cytokines [ Time Frame: 2 years ]
    Unit: µg/ml

  9. Clearance (CL) [ Time Frame: 2 years ]
    Unit: l/d*m²

  10. Volume distribution at steady state (Vdss) [ Time Frame: 2 years ]
    Unit: l/m²

  11. mean residence time (MRT) [ Time Frame: 2 years ]
    Unit: days

  12. half-life time (t1/2) [ Time Frame: 2 years ]
    Unit: days

  13. Area Under the Curve (AUC) [ Time Frame: 2 years ]
    Unit: µg*d/ml

  14. Maximum Plasma Concentration (Cmax) and Minimum Plasma Concentration (Cmin) [ Time Frame: 2 years ]
    Unit: µg/ml



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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary refractory or relapsed neuroblastoma.
  • Tumour burden controlled by conventional therapy (except patients with early minimal bone marrow relapse).
  • 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.
  • Patients should have a life expectancy of at least 12 weeks.

Exclusion Criteria:

  • Progressive disease at the time of inclusion into the study.
  • ADA positivity due to previous treatment with an anti-GD2 antibody (e.g. ch14.18/Mouse myeloma cell line SP2/0 (SP2/0), ch14.18/CHO).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743429


Contacts
Contact: Holger Lode, Professor +49 3834 86 6301 lode@uni-greifswald.de
Contact: Sandra Pasewald +49 3834 86 19463 sandra.pasewald@uni-greifswald.de

Locations
Germany
University Medicine Greifswald Recruiting
Greifswald, Germany
Contact: Holger N. Lode, Professor    +49 3834 86 6301    lode@uni-greifswald.de   
Contact: Silke Kietz, MD    +49 3834 86 6309    silke.kietz@uni-greifswald.de   
Sub-Investigator: Karoline Ehlert, MD         
Sponsors and Collaborators
University Medicine Greifswald
Children's Cancer Research Institute, Austria

Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT02743429     History of Changes
Other Study ID Numbers: APN311-304
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016

Keywords provided by University Medicine Greifswald:
ch14.18/CHO
neuroblastoma
long term infusion

Additional relevant MeSH terms:
Neuroblastoma
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
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs