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
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: dinutuximab beta||Phase 2|
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)|
|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|
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.
- 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.
- Progression-Free Survival [ Time Frame: 5 years ]
- 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
- Immunogenicity [ Time Frame: 2 years ]Immunogenicity: Anti-Drug Antibody (ADA)
- Immunophenotyping [ Time Frame: 2 years ]Unit: cells/µl
- Antibody dependent cellular cytotoxicity (ADCC) [ Time Frame: 2 years ]Unit: %
- Complement dependent cytotoxicity (CDC) [ Time Frame: 2 years ]Unit: %
- Whole Blood Test (WBT) [ Time Frame: 2 years ]Unit: %
- Cytokines [ Time Frame: 2 years ]Unit: µg/ml
- Clearance (CL) [ Time Frame: 2 years ]Unit: l/d*m²
- Volume distribution at steady state (Vdss) [ Time Frame: 2 years ]Unit: l/m²
- mean residence time (MRT) [ Time Frame: 2 years ]Unit: days
- half-life time (t1/2) [ Time Frame: 2 years ]Unit: days
- Area Under the Curve (AUC) [ Time Frame: 2 years ]Unit: µg*d/ml
- Maximum Plasma Concentration (Cmax) and Minimum Plasma Concentration (Cmin) [ Time Frame: 2 years ]Unit: µg/ml
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
|Contact: Holger Lode, Professor||+49 3834 86 firstname.lastname@example.org|
|Contact: Sandra Pasewald||+49 3834 86 email@example.com|
|University Medicine Greifswald||Recruiting|
|Contact: Holger N. Lode, Professor +49 3834 86 6301 firstname.lastname@example.org|
|Contact: Silke Kietz, MD +49 3834 86 6309 email@example.com|
|Sub-Investigator: Karoline Ehlert, MD|