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RECRUITING

NCT06071897

PHASE3

Induction Chemoimmunotherapy for Patients With High-risk Neuroblastoma

Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

View on ClinicalTrials.gov

Summary

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.

Official title: Introduction of Induction Chemoimmunotherapy Regimen for the Treatment of Pediatric Patients With Stage 4 High-risk Neuroblastoma and Ganglioneuroblastoma Older 18 Months

Key Details

Gender

All

Age Range

18 Months - 18 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-09-01

Completion Date

2029-09-01

Last Updated

2023-10-10

Healthy Volunteers

Conditions

Neuroblastoma Ganglioneuroblastoma

Interventions

DRUG

monoclonal antibodies GD2

Main target of this trial is to estimate tolerability and toxicity of combination of standard chemotherapy (N5 and N6) with anti-GD2 MAB N5Q. N5 (see above) Dinutuximab beta 10 mg/m2 i.v., days 5-9\* N6Q. N6 (see above) Dinutuximab beta 10 mg/m2 i.v., days 6-10\* G-CSF (granulocyte colony-stimulating factor) 5 mcg/kg s.c. on day 9 until the ANC is more than 2000 /ml or until counts have recovered for the next cycle of therapy

Inclusion Criteria: * Signed informed consent * Verified diagnosis of neuroblastoma or ganglioneuroblastoma (ICD-10 codes C47.3, C47.4, C47.5, C47.6, C47.8, C47.9, C48, C74.1, C74.9, C76.0, C76.1, C76.2, C76.7, C76.8). * High-risk patients in accordance with the risk stratification of to the GPOH-NB2004 protocol with stage 4 according to the International Neuroblastoma Staging System (INSS) from 18 months of life to 18 years. * ≥ 70% estimation by Lansky or Karnowski scale at the at the start point of chemoimmunotherapy. * Life expectancy ≥ 12 weeks from therapy initiation * No signs of drug-induced neuropathy or neuropathic pain. * Adequate liver function: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) activity \< 5 values of the upper limit of the norm (VGN). * Adequate renal function: creatinine clearance or glomerular filtration rate (GFR) \> 60 ml/min/1.73 m2. * Coagulogram parameters: prothrombin index (PTI) 70-120%, activated partial thromboplastin time (APTT) \< 36 s. * Absence of clinical signs of heart failure, left ventricular ejection fraction (LVEF) ≥ 55%. * Assessment of the function of the respiratory system (saturation on the pulse oximeter \> 94% without the use of oxygen, there is no respiratory disturbance at rest), the absence of pathology during chest X-ray. Exclusion Criteria: * Neuroblastoma or ganglioneuroblastoma of the low-risk group or intermediate-risk group, by NB 2004 protocol and disease staging according to INSS (stages 1-3 and 4s without apmplification of MYCN gene, stage 4 in patients under 18 months of age) and high-risk patients with stages 1-3/4s with amplification of MYCN gene. * Presence in anamnesis of acute intolerance reactions or contraindications to the main chemotherapeutic, immunobiological agents and any concomitant therapy drugs used within the framework of this clinical trial protocol. * Pregnancy due to the high teratogenic activity and toxicity of drugs used in the clinical trial protocol. A pregnancy test is indicated for patients of childbearing age.

Locations (1)

Research Institute of Pediatric Hematology, Oncology and Immunology

Moscow, Russia