Induction Chemoimmunotherapy for Patients With High-risk Neuroblastoma

Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Study ID
NCT06071897
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • monoclonal antibodies GD2 — DRUG
    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

Study Details

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.

Key Dates

First listed
Oct 10, 2023
Start date
Sep 1, 2023
Status verified
Sep 2023
Primary completion
Sep 1, 2026
Completion
Sep 1, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: intervention/treatment
    \* days of 21 days schedule N5 * Vincristine 1,5 mg/m2 i.v., day 1\* * Etoposide 100 mg/m2 i.v. , days 1-4\* * Cisplatin 100 mg/m2 i.v., days 1-4\* N6 * Vincristine 1,5 mg/m2 i.v. on days 1, 8\* * Dacarbasine 200 mg/m2 i.v., days 1-5\* * Ifosphamide 1500 mg/m2 i.v, days 1-5\* * Doxorubicin 30 mg/m2 i.v, days 6, 7\* N5Q * N5 (see above) * Dinutuximab beta 10 mg/m2 i.v., days 5-9\* 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 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 10 until the ANC is more than 2000 /ml or until counts have recovered for the next cycle of therapy 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.

Primary Outcome Measure

Estimate the Tolerability of the induction chemoimmunotherapy regimen based of courses N5 and N6 with anti-GD2 MAB measured by number of AEs (grade 1-2-3-4-5 measured by CTCAE v.5.0) [ Time Frame: 3 years after the start of therapy ]

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