Induction chemotherapy combined with immunotherapy for high-risk neuroblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates a new treatment approach for patients with high-risk neuroblastoma and ganglioneuroblastoma by combining standard chemotherapy with anti-GD2 monoclonal antibodies. The aim is to improve overall response rates, overall survival, and event-free survival by addressing tumor drug resistance through a synergistic effect of the therapies. The trial will monitor the tolerability and toxicity of this combination in patients aged 18 months to 18 years. Participants will receive the treatment during the induction phase of their therapy, while subsequent phases will not be analyzed.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Institute of Pediatric Hematology, Oncology and Immunology
  Moscow, Russia Recruiting

Study contacts

• Study coordinator: Denis Kachanov, MD,PhD
• Email: Denis.Kachanov@fccho-moscow.ru
• Phone: +7 495 664-77-40

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.