Actively Recruiting
A Randomized Phase III Study of Dinutuximab Beta With Chemotherapy in Patients Under 18 Years With GD2-Positive Bone and Soft Tissue Sarcomas After 1st Line Chemotherapy Progression
Led by N.N. Petrov National Medical Research Center of Oncology · Updated on 2024-11-01
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of dinutuximab beta combined with chemotherapy in patients under 18 years old with advanced or metastatic GD2-positive bone and soft tissue sarcomas, including rhabdomyosarcoma, Ewing sarcoma, and osteosarcoma, after their disease has progressed following first-line chemotherapy. The study plans to include data from 40 patients and randomize about 10 of them. Participants will receive six cycles of dinutuximab beta immunotherapy alongside 6 to 8 cycles of investigator-selected chemotherapy specific to their type of sarcoma. Chemotherapy regimens vary by sarcoma subtype and include combinations such as carboplatin, etoposide, ifosfamide, vincristine, cyclophosphamide, and others. Dinutuximab beta is administered as a slow intravenous infusion using a pump, and switching chemotherapy regimens during treatment is not allowed. During the study, treatment response will be assessed after 2 and 4 cycles and at the end of treatment using tumor response criteria (RECIST 1.1). After treatment ends or disease progression occurs, patients will be followed monthly for up to six months to monitor survival and safety, unless consent is withdrawn. The primary outcome measured is progression-free survival at six months, with secondary outcomes including overall survival, tumor control rate, and immune-related side effects.
CONDITIONS
Brief 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 with one or more lines of chemotherapy and relapsed or refractory
- Good general condition (Lansky scale 80-100% for under 16 years; Karnofsky scale 80-100% for over 16 years; ECOG 0-1)
- Adequate cardiopulmonary reserves (normal ECG, ventricular ejection fraction > 75% of upper limit)
- Adequate liver, kidney, and bone marrow function
- Life expectancy 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 cycles of dinutuximab beta and 6 to 8 cycles of chemotherapy
Participants receive 6 cycles of dinutuximab beta immunotherapy combined with 6 to 8 cycles of chemotherapy. Treatment continues until disease progression with chemotherapy regimens fixed per participant without switching.
Visits occur during each treatment cycle with assessments after 2, 4, and 6 cycles
Duration - 6 months
After treatment ends, participants are followed monthly for up to 6 months to assess survival and monitor health status until death, withdrawal, or study end.
Monthly visits for up to 6 months
Trial Site Locations
Total: 1 location
1
Kulyova Svetlana
Saint Petersburg, Russia, 194362
Actively Recruiting
Research Team
S
Svetlana Kulyova, MD, Phd
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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