Chemo-immunotherapy in Patients Under 18 Years of Age With Bone and Soft Tissue Sarcomas
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorN.N. Petrov National Medical Research Center of Oncology
About this trial
Data from 40 patients are planned to be included in the study to randomize approximately 10 patients.
This study involves patients with advanced/metastatic GD2-positive rhabdomyosarcoma after progression on 1st line of chemotherapy, advanced/metastatic GD2-positive Ewing sarcoma after progression on 1st line of chemotherapy and advanced/metastatic GD2-positive osteosarcoma after progression on 1st line of chemotherapy.
All patients will receive therapy until disease progression (a total of 6 courses of immunotherapy).
The primary objective of the study is to determine the efficacy and safety of dinutuximab beta with investigator's choice of chemotherapy.
Eligibility criteria
Qualifiers
Signed written informed consent form;
Age under 18 years of age;
Histologically confirmed GD2-positive osteogenic sarcoma, Ewing's sarcoma, soft tissue and undifferentiated sarcomas;
Prior to study enrollment, patients must have been treated with one or more lines of adequate chemotherapy and must have relapsed on this therapy or have refractoriness to it;
Disqualifiers
Withdrawal of consent by the patient or his/her parent/guardian.
Exclusion of the patient by the investigator for safety or ethical reasons.
Trial design
Treatments tested in this trial
- dinutuximab beta
Treatment groups
40 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov