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New treatment option for Neuroblastoma (NB)
Official title Chemoimmunotherapy Combined With Autologous NK Cell Therapy for Pediatric Patients With Refractory and Relapsed High-Risk Neuroblastoma and Ganglioneuroblastoma
ClinicalTrials.gov ID: NCT07375563
What this study is testing
What is Dinutuximab beta, temozolomide, irinotecan, autologous NK cell?
Dinutuximab beta, temozolomide, irinotecan, autologous NK cell is an investigational medicine, being studied as a potential treatment for neuroblastoma (nb).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Neuroblastoma (NB) is a malignant neoplasm of the sympathetic nervous system, occurring in 1 in 8,000 live births, accounting for 6-10% of all childhood malignant neoplasms and responsible for 12-15% of mortality -, making it the most common and life-threatening extracranial tumor in childhood. Patients with stage 4 high-risk NB is the subgroup with the poorest prognosis.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 18
You may be able to join if
- Signed voluntary informed consent to participate in the clinical trial
- Histologically verified diagnosis of neuroblastoma or ganglioneuroblastoma
- Patients stratified to the high-risk group according to the criteria of the German Society of Pediatric Oncology and Hematology (GPOH) - NB 2004...
- Arm A: Refractory disease - patients who have completed the induction phase of therapy (6 cycles of N5/N6) with a poor response to therapy (MR, SD)...
- Arm В: Relapsed/progressive disease - patients who develop any new tumor lesions (after having previously achieved СR), or any new tumor lesion; an...
You likely can't join if
- Lack of a signed voluntary informed consent form for participation in the clinical study.
- Absence of comprehensive pre-treatment assessment results at the time of initiation of specific therapy.
- Patients with NBL or ganglioneuroblastoma stratified to low or intermediate-risk group
- Good response (PR, VGPR, CR) or PD at the end of the induction phase of therapy (applicable only to patients receiving therapy within the framework...
- Progressive or relapsed disease with central nervous system involvement and/or leptomeningeal involvement.
- History of acute intolerance reactions to the main chemotherapeutic and immunobiological agents and supportive care drugs used in this clinical trial...
See the full eligibility criteria
- Signed voluntary informed consent to participate in the clinical trial
- Histologically verified diagnosis of neuroblastoma or ganglioneuroblastoma
- Patients stratified to the high-risk group according to the criteria of the German Society of Pediatric Oncology and Hematology (GPOH) - NB 2004, aged from 18 months to 18 years, and meeting the following conditions:
- Arm A: Refractory disease - patients who have completed the induction phase of therapy (6 cycles of N5/N6) with a poor response to therapy (MR, SD), with the exception of PD
- Arm В: Relapsed/progressive disease - patients who develop any new tumor lesions (after having previously achieved СR), or any new tumor lesion; an increase of \>25% in any previously existing measurable lesion; or...
- Performance status ≥ 70% (Lansky or Karnofsky scale) at the time of determining the indication for chemoimmunotherapy combined with NK cell therapy.
- Expected life expectancy ≥ 12 weeks.
- No signs of drug-induced neuropathy or neuropathic pain.
- Adequate liver function: alanine aminotransferase (ALT) / aspartate aminotransferase (AST) activity \< 5 × upper limit of normal (ULN).
- Adequate renal function: creatinine clearance or glomerular filtration rate (GFR) \> 60 mL/min/1.73 m².
- Coagulation parameters: prothrombin index (PTI) 70-120%; activated partial thromboplastin time (APTT) \< 36 seconds.
- No clinical signs of heart failure; left ventricular ejection fraction (LVEF) ≥ 55%.
- Adequate respiratory function (oxygen saturation by pulse oximetry \> 94% on room air, no dyspnea at rest), and no pathological findings on chest X-ray.
- Completion of comprehensive assessment to evaluate the extent of the tumor process.
- Lack of a signed voluntary informed consent form for participation in the clinical study.
- Absence of comprehensive pre-treatment assessment results at the time of initiation of specific therapy.
- Patients with NBL or ganglioneuroblastoma stratified to low or intermediate-risk group
- Good response (PR, VGPR, CR) or PD at the end of the induction phase of therapy (applicable only to patients receiving therapy within the framework of the intensified induction phase).
- Progressive or relapsed disease with central nervous system involvement and/or leptomeningeal involvement.
- History of acute intolerance reactions to the main chemotherapeutic and immunobiological agents and supportive care drugs used in this clinical trial protocol.
- Presence of complications of the underlying disease and comorbidities that preclude treatment within this protocol, including severe type I hypersensitivity reactions in the medical history.
- Requirement for concomitant medications with known cross pharmacodynamic interactions with the drugs used in this clinical trial protocol.
- Presence of ultrasonographic signs of heart failure (LVEF ≤ 55%), clinical and laboratory signs of chronic kidney disease of stage ≥ III, or kidney injury of grade I, F or L according to the standardized RIFLE criteria...
- Pregnancy, due to the high teratogenicity and toxicity of the drugs used in this clinical trial protocol. Female patients of childbearing potential are required to undergo pregnancy testing.
- Mental illness of the patient or legal guardians that makes it impossible to understand the nature of the study and compromises adherence to medical prescriptions and sanitary-hygienic requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 months to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.