Actively Recruiting
Induction Chemoimmunotherapy for Patients With High-risk Neuroblastoma
Led by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Updated on 2023-10-10
15
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The modern strategy of therapy of high-risk neuroblastoma, stage 4, consists of three phases - induction, consolidation and post- consolidation. Still current approaches demonstrates insufficient levels of ORR (overall response rate), OS (overall survival) and EFS (event free survival). NB-HR-2023 (neuroblastoma high risk) protocol aimed to investigate tolerability and toxicity and potential improvement of ORR, OS and EFS by overcoming of tumor heterogeneous drug resistance using the synergistic interaction of cytostatic and immunobiological agents in the induction. Protocol include the combination of standard chemotherapy (N5 and N6) with anti-GD2 MAB, which is potentially expected to improve outcomes in patients with high-risk neuroblastoma and ganglioneuroblastoma, 4th stage older 18 months. Currently, treatment with combinations of cytostatics with immunobiological agents is limited due to the risk of complications, which, nevertheless, is controlled with proper monitoring and concomitant therapy. Still no data about use of combination of standard chemotherapy (N5 and N6) with ch14.18/CHO MAB (dinutuximab beta) in induction in primary patients with neuroblastoma. Prospective, interventional trial include patients with neuroblastoma and ganglioneuroblastoma, 4th stage of the high-risk group older 18 months, who will receive combination of standard induction chemotherapy (N5 and N6) with anti-GD2 MAB. Consolidation and post consolidation chemotherapy courses are not the subjects for analysis. Patients with high-risk neuroblastoma and ganglioneuroblastoma, stage 4, older 18 months who receive combination of standard induction chemotherapy (N5 and N6) with anti-GD2 MAB at the Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology Delayed surgery (if needed) will be done after the 4th or 6th course of induction therapy and stem cells apheresis after the 2nd-5th course of induction therapy.
CONDITIONS
Official Title
Induction Chemoimmunotherapy for Patients With High-risk Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Confirmed diagnosis of neuroblastoma or ganglioneuroblastoma
- Stage 4 high-risk disease according to GPOH-NB2004 protocol and INSS, aged 18 months to 18 years
- Lansky or Karnowski performance score of 70% or higher at treatment start
- 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 upper limit of normal
- 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 without oxygen support and no chest X-ray abnormalities
You will not qualify if you...
- Neuroblastoma or ganglioneuroblastoma of low or intermediate risk groups, or stage 4 in children under 18 months without MYCN gene amplification
- High-risk patients with stages 1-3 or 4s with MYCN gene amplification
- History of acute intolerance or contraindications to chemotherapy or immunotherapy drugs used in this trial
- Pregnancy or positive pregnancy test in patients of childbearing age
AI-Screening
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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
CONTACT
E
Elena Smirnova
CONTACT
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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