Dinutuximab-beta and Chemotherapy in Newly Diagnosed High-Risk Neuroblastoma

Ki vehet részt

• Must be 1 to 30 years of age at the time of initial diagnosis
• Must have histological verification of neuroblastoma or ganglioneuroblastoma, OR demonstration of neuroblastoma cells in the bone marrow with elevated urinary VMA at the time of initial diagnosis
• Must have newly diagnosed high-risk neuroblastoma according to the revised COG NBL risk classifier (version 2), defined as meeting at least ONE of the following:; INRG Stage M: MYCN amplification (> 4-fold increase), OR age 12 to < 18 months without MYCN amplification but with unfavorable histology/DI = 1/SCA, OR age > 18 months regardless of biologic features; INRG Stage MS: MYCN amplification, OR age 12 to < 18 months without MYCN amplification but with unfavorable histology/DI = 1/SCA; INRG Stage L2: MYCN amplification, OR age 18 months to < 5 years without MYCN amplification but with unfavorable histology, OR age ≥ 5 years without MYCN amplification but with unfavorable histology (undifferentiated or poorly differentiated tumor); INRG Stage L1: Tumor with incomplete resection and MYCN amplification; Patients > 18 months of age initially diagnosed with INRG Stage L1, L2, or MS who are subsequently upgraded to high-risk disease
• Must have had no prior systemic therapy, or have only completed the first cycle of induction chemotherapy under the TPOG N2020-HR protocol
• Must have measurable disease, defined as at least ONE of the following (Note: Patients with elevated VMA only are NOT eligible):; Measurable tumor on MRI or CT scan within 3 weeks prior to study entry (≥ 10 mm in at least one dimension) that is MIBG avid or demonstrates increased FDG/FDOPA uptake on PET scan; MIBG or FDG/FDOPA PET scan within 2 weeks prior to study entry with positive uptake at a minimum of one site
• ECOG Performance Status of 0, 1, or 2
• Adequate organ function, including:; Renal: Creatinine clearance or estimated GFR ≥ 60 mL/min/1.73 m², or serum creatinine ≤ upper limit of normal (ULN) based on age/gender; Liver: Total bilirubin ≤ 1.5 x ULN for age AND SGPT (ALT) ≤ 5.0 x ULN (if liver tumor is present) or ≤ 3.0 x ULN (if no liver tumor); CNS: No clinical or radiological evidence of active CNS disease (well-controlled seizures allowed), and CNS toxicity ≤ Grade 2; Cardiac: Shortening fraction ≥ 27% or Ejection fraction ≥ 50% by ECHO or gated radionuclide study; Pulmonary: No dyspnea at rest, no exercise intolerance, no chronic oxygen requirement, and room air pulse oximetry > 94%
• Must be enrolled on the TPOG N2020-GD2 protocol with completed informed consent forms, and be willing to proceed to standard therapy of high-risk neuroblastoma with a 10-year follow-up

Ki nem vehet részt

• Females who are pregnant or breastfeeding (A pregnancy test is required for female patients of childbearing potential); Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential; Lactating females who plan to breastfeed their infants; The subject or their partner is planning to conceive; Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method during study therapy and for two months after the last dose of (ch14.18/CHO) (dinutuximab-β) are not eligible
• Patients with bone marrow failure syndromes
• Current requirement for immunosuppressive medications (e.g., tacrolimus, cyclosporine, systemic corticosteroids for reasons other than prevention/treatment of acute allergic reactions or adrenal replacement therapy)
• Participation in other interventional clinical trials within 1 month
• Inability to obey the trial instructions