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New treatment option for Neuroblastoma
Official title Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma
ClinicalTrials.gov ID: NCT06485947
What this study is testing
What is Dinutuximab beta?
Dinutuximab beta is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuroblastoma.
Also referred to as Immunotherapy.
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
- The goal of this clinical trial is to to assess the dose level of dinutuximab Beta (DB) when combined with 2 different induction chemotherapy regimens (named GPOH or rapid COJEC) in newly diagnosed high-risk neuroblastoma patients. The main question is: to assess the safety and tolerability and identifying the recommended phase II dose and/or the maximum tolerable dose of dinutiximab Beta when combined with 2 standard induction chemotherapy regimens Participants will receive: GPOH + dinutuximab beta infusion duration = 10 mg/m2 × 5 days (50 mg/m2/course) in 21-day treatment intervals.
- Phase 1: an early, usually small safety 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
- Established diagnosis of neuroblastoma Stage M, according to the SIOPEN modified International Neuroblastoma Risk Group (INRG) and to the INSS...
- Age ≥18 months and \<18 years.
- Body weight \>12 kg.
- Alanine transaminase and aspartate aminotransferase \<10 × upper limit of normal (ULN), total bilirubin \<1.5 × ULN based on age specific reference...
- Calculated glomerular filtration rate \> 60 mL/min/1.73 m2 or serum creatinine \<1.5 × ULN corrected for age.
You likely can't join if
- Previous cancer-specific treatment for neuroblastoma.
- Current use of a prohibited medication or requires any of these medications during the study:
- Treatment with corticosteroids is not allowed within 2 weeks prior to the first block of chemotherapy and until 1 week after the last treatment...
- Vaccinations (including seasonal influenza) are not allowed during administration of dinutuximab beta and until 10 weeks after last treatment course.
- Concomitant use of intravenous (IV) immunoglobulins is not allowed.
- Concomitant use of cardioprotectant dexrazoxane is not allowed.
See the full eligibility criteria
- Established diagnosis of neuroblastoma Stage M, according to the SIOPEN modified International Neuroblastoma Risk Group (INRG) and to the INSS criteria (Appendix 1).
- Age ≥18 months and \<18 years.
- Body weight \>12 kg.
- Alanine transaminase and aspartate aminotransferase \<10 × upper limit of normal (ULN), total bilirubin \<1.5 × ULN based on age specific reference ranges.
- Calculated glomerular filtration rate \> 60 mL/min/1.73 m2 or serum creatinine \<1.5 × ULN corrected for age.
- Shortening fraction (SF) ≥27% and/or left ventricular ejection fraction (LVEF) \>50% as determined by echocardiography or MUGA.
- Able to comply with scheduled follow-up and study procedures.
- Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study specific screening procedures are conducted, according to local, regional or national law and legislation.
- Previous cancer-specific treatment for neuroblastoma.
- Current use of a prohibited medication or requires any of these medications during the study:
- Treatment with corticosteroids is not allowed within 2 weeks prior to the first block of chemotherapy and until 1 week after the last treatment course with dinutuximab beta, except for life-threatening conditions.
- Vaccinations (including seasonal influenza) are not allowed during administration of dinutuximab beta and until 10 weeks after last treatment course.
- Concomitant use of intravenous (IV) immunoglobulins is not allowed.
- Concomitant use of cardioprotectant dexrazoxane is not allowed.
- Pregnancy or positive pregnancy test in females of childbearing potential.
- Breast feeding.
- Sexually active participants not willing to use highly effective contraceptive method
- Major surgery within 21 days prior to the first treatment dose
- History or documented evidence of severe acute or chronic infection or infectious illness requiring parenteral therapy unless fully healed
- Patients with spinal cord involvement
- Any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an...
- Have a known immediate or delayed hypersensitivity reaction to study drugs
The study team makes the final eligibility decision.
Where it's taking place
- Utrecht, Utrecht, Netherlands
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 Utrecht, Utrecht, Netherlands. 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.