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CESS-GD2
International Phase I Trial of Dinutuximab Beta With VDC/IE in GD2-Positive Ewing Sarkoma
International open-label phase I dose escalation study of dinutuximab beta in combination with vincristine/doxorubicin/cyclophosphamide and ifosfamide/etoposide in pediatric, adolescent, and adult patients with GD2-positive Ewing sarcoma
Recruiting
Summary
The goal of the study is to investigate the feasibility, toxicity, and biological activity of the treatment with dinutuximab beta in combination with standard chemotherapy in EWS to give high-risk patients with a GD2 positiv pumor a benefit in treatment. Within the study is tested with three different dosages in a 3+3 design with three pre-defined dose levels.
Main inclusion criteria
- Age ≥12 months
- Histologically confirmed, newly diagnosed Ewing Sarcoma or so-called Ewing-like sarcoma (i.e. translocation-positive small blue round cell sarcoma other than Rhabdomyosarcoma) of bone and / or soft tissue
- Centrally
confirmed GD2 expression in tumor tissue (from biopsy or liquid biopsy)
- Lansky (<16 years) Performance Score ≥70% or ECOG (≥16 years) ≤ 2
Sponsor
GPOH gGmbH