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

NCT02743429 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-10-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Children's Cancer Research Institute, Austria

    collaborator OTHER

  • University Medicine Greifswald

    lead OTHER

Principal Investigators

  • Holger Lode, Professor · University Medicine Greifswald

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-27
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02743429 on ClinicalTrials.gov