Viewing Study NCT06071897



Ignite Creation Date: 2024-05-06 @ 7:36 PM
Last Modification Date: 2024-10-26 @ 3:10 PM
Study NCT ID: NCT06071897
Status: RECRUITING
Last Update Posted: 2023-10-10
First Post: 2023-09-18

Brief Title: Induction Chemoimmunotherapy for Patients With High-risk Neuroblastoma
Sponsor: Federal Research Institute of Pediatric Hematology Oncology and Immunology
Organization: Federal Research Institute of Pediatric Hematology Oncology and Immunology

Study Overview

Official Title: Introduction of Induction Chemoimmunotherapy Regimen for the Treatment of Pediatric Patients With Stage 4 High-risk Neuroblastoma and Ganglioneuroblastoma Older 18 Months
Status: RECRUITING
Status Verified Date: 2023-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 ch1418CHO 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
Detailed Description: 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 protocol aimed to investigate 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

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 anti-GD2 MAB in induction

Main target of this trial is to estimate tolerability and toxicity of combination of standard chemotherapy N5 and N6 with anti-GD2 MAB Prospective interventional trial include patients with high-risk neuroblastoma and ganglioneuroblastoma 4th stage 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 n15 with high-risk neuroblastoma and ganglioneuroblastoma 4th stage 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

Patients to be enrolled should met the eligibility criteria see below and will receive the induction therapy two courses of standard chemotherapy and four courses of combination of anti-GD2 МАB ch1418CHO dinutuximab beta

N5Q cycle cisplatin 40 mgm2 per day IV in days 1-4 etoposide 100 mgm2 per day IV days 1-4 vincristine 15 mgm2 per day IV day 1 dinutuximab beta 10 mgm2 per day IV Days 5-9 N6Q cycle vincristine 15 mgm2 per day IV days 1 8 dacarbazine 200 mgm2 per day IV days 1-5 ifosfamide 1500 mgm2 per day IV days 1-5 doxorubicin 30 mgm2 per day IV days 6 7 dinutuximab beta 10 mgm2 per day IV days 6-10

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

Interim analyses will be carried out in 1 2 and 3 years from the first patient enrollement

The final analysis with the assessment of the ORR OS EFS of patients will be carried out in 1 year and 3 years from the date of inclusion of the last patient in the protocol

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None