Actively Recruiting
Chemo-immunotherapy in Patients Under 18 Years of Age With Bone and Soft Tissue Sarcomas
Led by N.N. Petrov National Medical Research Center of Oncology · Updated on 2024-11-01
40
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Chemo-immunotherapy in Patients Under 18 Years of Age With Bone and Soft Tissue Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent form
- Under 18 years of age
- Histologically confirmed GD2-positive osteogenic sarcoma, Ewing's sarcoma, soft tissue or undifferentiated sarcomas
- Treated previously with one or more lines of adequate chemotherapy and relapsed or refractory
- General condition satisfactory (Lansky scale 80-100% for children under 16, Karnofsky scale 80-100% for children over 16, ECOG 0-1)
- Sufficient cardiopulmonary reserves (normal ECG, ventricular ejection fraction > 75% of upper normal limit)
- Adequate liver function (ALT ≤ 2.5 × VGN, AST ≤ 2.5 × VGN), kidney function (creatinine < 1.5 × VGN), and bone marrow function (granulocytes > 2.0 × 10^9/L, platelets > 150 × 10^9/L)
- Life expectancy of at least 12 months at therapy initiation
- Oligometastatic disease with 1 to 5 distant metastatic sites at restaging
You will not qualify if you...
- Withdrawal of consent by patient or parent/guardian
- Exclusion by investigator for safety or ethical reasons
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kulyova Svetlana
Saint Petersburg, Russia, 194362
Actively Recruiting
Research Team
S
Svetlana Kulyova, MD, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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