2023-509673-22-00招募中2 期
Phase Ib study combining dinutuximab beta with induction chemotherapy regimens in patients with newly diagnosed high-risk neuroblastoma: SIOPEN-Pilot01
Prinses Maxima Centrum voor Kinderoncologie B.V.9 个研究点 分布在 4 个国家目标入组 36 人开始时间: 2024年6月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 9
- 主要终点
- Incidence of dose limiting toxicities (DLTs) associated with the combination of dinutuximab beta with GPOH (2 DLT evaluation cycles: first N6 and second N5 cycles) or rapid COJEC (first C and second B and A cycles) induction chemotherapy regimens.
研究概览
简要总结
• To assess the safety and tolerability and identify the RP2D and MTD of dinutuximab beta when combined with two different induction chemotherapy regimens (GPOH or rapid COJEC) for the treatment of newly diagnosed high-risk neuroblastoma patients as defined by Stage M ≥ 18 months of age and <18 years, according to the INRGSS.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Established diagnosis of neuroblastoma Stage M, according to the SIOPEN modified International Neuroblastoma Risk Group (INRG) and to the INSS criteria
- •Age ≥18 months and <18 years
- •Body weight >12 kg.
- •Alanine transaminase (ALT) and aspartate aminotransferase (AST) <10 × upper limit of normal (ULN), total bilirubin <1.5 × ULN based on age specific reference ranges
- •Calculated glomerular filtration rate (based on Schwartz formula; section 10.4.7) >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.
排除标准
- •Previous cancer-specific treatment for neuroblastoma
- •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 investigational drug or places the patient at unacceptable risk from treatment complications.
- •Patients with pre-existing grade 3-4 neurological toxicity.
- •Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drugs, or drugs chemically related to study treatment or excipients that contraindicate their participation, including conventional chemotherapeutics and dinutuximab beta.
- •Current use of a prohibited medication or requires any of these medications during the study (See Section 8.1.2 for details): a. Treatment with corticosteroids is not allowed within 2 weeks prior to the first treatment course and until 1 week after the last treatment course with dinutuximab beta, except for life-threatening conditions. b. Vaccinations (including seasonal influenza) are not allowed during administration of dinutuximab beta and until 10 weeks after last treatment course. c. Concomitant use of intravenous (IV) immunoglobulins is not allowed. d. Concomitant use of cardioprotectant dexrazoxane is not allowed.
- •Pregnancy or positive pregnancy test (urine or serum) in females of childbearing potential. Pregnancy test must be performed within 7 days prior to C1D1
- •Breast feeding
- •Sexually active participants not willing to use highly effective contraceptive method (pearl index <1) as defined in CTFG HMA 2020 (Appendix 2) during trial participation and until 6 months after end of protocol therapy
- •Major surgery within 21 days prior to enrollment of the first treatment dose (open tumor biopsy or central line placement is not considered major surgery).
- •History or documented evidence of severe acute or chronic infection or infectious illness requiring parenteral therapy unless fully healed (Grade <1) at least 4 weeks prior to start of treatment
- •Patients with spinal cord involvement (symptomatic patients or if identified on imaging done to establish the diagnosis; there is no screening for spinal cord involvement for all patients).
结局指标
主要结局
Incidence of dose limiting toxicities (DLTs) associated with the combination of dinutuximab beta with GPOH (2 DLT evaluation cycles: first N6 and second N5 cycles) or rapid COJEC (first C and second B and A cycles) induction chemotherapy regimens.
Incidence of dose limiting toxicities (DLTs) associated with the combination of dinutuximab beta with GPOH (2 DLT evaluation cycles: first N6 and second N5 cycles) or rapid COJEC (first C and second B and A cycles) induction chemotherapy regimens.
次要结局
- Type, incidence, severity, seriousness and relationship to study medications for Grade 3 and 4 AEs, including laboratory abnormalities and severe adverse events (SAEs). • Cumulative incidence of treatment-related mortality and of disease-related mortality.
- Overall response during and after induction (primary tumor, metastases).
- mCR after induction treatment. mPR according to eligibility criteria to proceed to consolidation by HDC/ASCT: mPR for bone disease: MIBG uptake (or FDG-PET uptake for MIBG-non avid tumors) completely resolved or SIOPEN score ≤3 and at least 50% reduction in MIBG score (or ≤3 bone lesions and at least 50% reduction in number of FDG-PET-avid bone lesions for MIBG-non avid tumors). mPR for bone marrow disease: CR and/or MD according to INRC. mPR for other metastatic sites
研究者
Paco Bautista
Scientific
Prinses Maxima Centrum voor Kinderoncologie B.V.
研究点 (9)
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