EUCTR2015-003130-27-GB进行中（未招募）1 期
An international multicenter phase II randomised trial evaluating and comparing two intensification treatment strategies for metastatic neuroblastoma patients with a poor response to induction chemotherapy - VERITAS
Gustave Roussy0 个研究点目标入组 150 人开始时间: 2019年2月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Metastatic neuroblastoma (NBL)
- •2.Previously treated within the SIOPEN High Risk Neuroblastoma study or treated with the current standard treatment for very high risk neuroblastoma off-trial (Rapid COJEC induction chemotherapy)
- •3.131I-mIBG scintigraphy positive at diagnosis and after induction chemotherapy (pre BuMel evaluation).
- •4.Metastatic response after induction chemotherapy lower than the SIOPEN High Risk Neuroblastoma trial criteria to be eligible for high dose chemotherapy (metastatic response worse than partial response (< PR) or SIOPEN score > 3)
- •5.Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment. Sexually active patients must agree to use acceptable and appropriate contraception while on study drug and for one year after stopping the study drug. Acceptable contraception is listed in Appendix 12. Female patients who are lactating must agree to stop breast-feeding.
- •6.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 guidelines.
- •7.Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Parenchymal brain metastasis(es) (even one)
- •2.Progressive disease at study entry
- •3.Previous high-dose therapy and ASCR
- •4.Performance status (Karnofsky or Lansky) <70%
- •5.Patient having received other therapy for cancer treatment than those allowed as per the SIOPEN High Risk Neuroblastoma trial or as defined in the future frontline protocol (for HRNBL1 trial : after induction + 2 TVD)
- •6.Impaired organ function (liver, kidney, heart, lungs) according to the following definitions
- •oShortening fraction <28%, or ejection fraction <55%, or clinical evidence of congestive heart failure or uncontrolled cardiac rhythm disturbance
- •oDyspnea at rest and/or pulse oximetry <95% in air.
- •oALT, Bilirubin > 2 ULN
- •oCreatinine clearance and/or GFR < 60 ml/min/1.73m2 and serum creatinine = 1.5 mg/dl
- •7.Any uncontrolled inter-current illness or infection that in the investigator’s opinion would impair study participation
- •8.Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines
- •9.Patient allergic to peanut or soya
- •10.Chronic inflammatory bowel disease and/or bowel obstruction
- •11.Pregnant or breastfeeding women
- •12.Known hypersensitivity to the active substance or to any of the excipients of study drugs
- •13.Known hypersensitivity to dacarbazine
- •14.Concomitant use with St John's Wort
研究者
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