Status:
RECRUITING
Induction Chemoimmunotherapy for Patients With High-risk Neuroblastoma
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Conditions:
Neuroblastoma
Ganglioneuroblastoma
Eligibility:
All Genders
18-18 years
Phase:
PHASE3
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 leve...
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 leve...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06071897
Start Date
September 1 2023
End Date
September 1 2029
Last Update
October 10 2023
Active Locations (1)
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1
Research Institute of Pediatric Hematology, Oncology and Immunology
Moscow, Russia, 117997