NCT02743429

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-03-27
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2016-04-19
• Last updated: 2021-10-04

Locations

2 sites across 2 countries: Austria, Germany