Actively Recruiting
Induction Chemoimmunotherapy Regimen for Pediatric Patients With Stage 4 High-risk Neuroblastoma and Ganglioneuroblastoma Older Than 18 Months
Led by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Updated on 2023-10-10
15
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating new treatment options for children and adolescents aged 18 months to 18 years with stage 4 high-risk neuroblastoma or ganglioneuroblastoma. Current treatments show limited success in response rates and survival outcomes. This study aims to improve these results by combining standard chemotherapy with an immunotherapy drug called anti-GD2 monoclonal antibody (dinutuximab beta) during the initial phase of treatment. The study involves giving participants a combination of chemotherapy cycles labeled N5 and N6 alongside the anti-GD2 antibody. The N5 cycle includes vincristine, etoposide, cisplatin, and dinutuximab beta, while the N6 cycle combines vincristine, dacarbazine, ifosfamide, doxorubicin, and dinutuximab beta. Granulocyte colony-stimulating factor (G-CSF) is also administered to support blood cell recovery. Surgery, if needed, will be delayed until after the 4th or 6th induction cycle, and stem cell collection will occur between the 2nd and 5th cycles. The study focuses on the induction phase and does not analyze later consolidation treatments. Participants will be closely monitored for side effects and treatment tolerance using standardized criteria over three years. Researchers will assess overall response rates, survival, and event-free survival at specific time points after treatment completion. The study includes clinical evaluations, laboratory tests, imaging, and toxicity assessments. This comprehensive monitoring aims to understand the safety and potential improvements of this combined chemoimmunotherapy approach in high-risk neuroblastoma patients.
CONDITIONS
Brief Title
Induction Chemoimmunotherapy for Patients With High-risk Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Diagnosis of neuroblastoma or ganglioneuroblastoma confirmed
- Stage 4 high-risk disease according to INSS, aged 18 months to 18 years
- Lansky or Karnowski performance score of at least 70%
- Life expectancy of at least 12 weeks from therapy start
- No signs of drug-induced neuropathy or neuropathic pain
- Adequate liver function: ALT/AST less than 5 times the upper normal limit
- Adequate kidney function: creatinine clearance or GFR above 60 ml/min/1.73 m2
- Coagulation parameters within specified ranges
- No clinical signs of heart failure; LVEF at least 55%
- Normal respiratory function and chest X-ray without pathology
You will not qualify if you...
- Low- or intermediate-risk neuroblastoma or ganglioneuroblastoma, or stage 4 disease in children under 18 months without MYCN amplification
- High-risk stages 1-3/4s with MYCN gene amplification
- History of acute intolerance or contraindication to chemotherapy or immunotherapy drugs used in this trial
- Pregnancy; pregnancy test required for patients of childbearing potential
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks (6 cycles of 21 days each)
Participants receive induction chemoimmunotherapy consisting of two courses of standard chemotherapy (N5 and N6) combined with four courses of anti-GD2 monoclonal antibody dinutuximab beta. Each course lasts 21 days, with treatment including intravenous chemotherapy and immunotherapy infusions, as well as supportive therapy with G-CSF. Some participants may undergo delayed surgery after the 4th or 6th course and stem cell apheresis after the 2nd to 5th course.
6 cycles with multiple visits per cycle including days 1-10 infusions and monitoring
Duration - Up to 3 years after treatment completion
Participants are monitored for tolerability, toxicity, overall response rate, overall survival, and event-free survival at 1 and 3 years after completing induction therapy.
Interim analyses at 1, 2, and 3 years; final analyses at 1 and 3 years after last patient inclusion
Trial Site Locations
Total: 1 location
1
Research Institute of Pediatric Hematology, Oncology and Immunology
Moscow, Russia, 117997
Actively Recruiting
Research Team
D
Denis Kachanov, MD,PhD
E
Elena Smirnova
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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