Ewing Sarcoma
Conditions
Brief summary
The primary endpoint is the identification of the recommended phase II dose (RP2D) of dinutuximab beta in combination with vincristine, doxorubicin, and cyclophosphamide, as well as ifosfamide and etoposide, based on the evaluation of dose-limiting toxicities (DLTs), overall safety, and tolerability within the study population.
Detailed description
Progression-Free Survival (PFS): The time from the start of treatment until the first documented evidence of disease progression or death from any cause, whichever occurs first., Event-Free Survival (EFS): The time from the initiation of treatment to the occurrence of any treatment-related event, including disease progression, relapse, occurrence of a second malignancy, or death from any cause., Duration of Response (DOR): The time from the first documentation of a complete or partial response to the treatment until the first occurrence of disease progression or relapse.
Interventions
DRUGMESNA
DRUGIFOSFAMIDE
DRUGFILGRASTIM
DRUGVINCRISTINE SULFATE
DRUGDOXORUBICIN
DRUGCYCLOPHOSPHAMIDE
DRUGETOPOSIDE
DRUGDINUTUXIMAB BETA
Sponsors
GPOH gGmbH
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the identification of the recommended phase II dose (RP2D) of dinutuximab beta in combination with vincristine, doxorubicin, and cyclophosphamide, as well as ifosfamide and etoposide, based on the evaluation of dose-limiting toxicities (DLTs), overall safety, and tolerability within the study population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS): The time from the start of treatment until the first documented evidence of disease progression or death from any cause, whichever occurs first., Event-Free Survival (EFS): The time from the initiation of treatment to the occurrence of any treatment-related event, including disease progression, relapse, occurrence of a second malignancy, or death from any cause., Duration of Response (DOR): The time from the first documentation of a complete or partial response to the treatment until the first occurrence of disease progression or relapse. | — |
Countries
Austria, Czechia, Germany, Sweden
Outcome results
None listed