NL-OMON49491已完成2 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 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •1. Metastatic neuroblastoma (NBL).
- •2. Previously treated within the ongoing High Risk Neuroblastoma SIOPEN study.
- •3. 131I-mIBG scintigraphy positive at diagnosis and after induction
- •chemotherapy (before high-dose BuMel + ASCT).
- •4. Metastatic response after induction chemotherapy lower to the ongoing High
- •Risk Neuroblastoma
- •SIOPEN 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 are defined in CTFG Guidelines *Recommendations related to
- •contraception and
- •pregnancy testing in clinical trials*. Female patients who are lacting must
- •agree to stop breastfeeding.
- •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.
排除标准
- •1. Parenchymal brain metastasis(es) (even one)
- •2. Progressive disease at study entry
- •3. Previous high-dose therapy and PBSCT
- •4. Performance status (Karnofsky or Lansky) <70%
- •5. Patient having received other therapy for cancer treatment than those
- •allowed as per the ongoing
- •High Risk Neuroblastoma SIOPEN trial or as defined in the future frontlines
- •protocol (for HRNBL1
- •trial : after induction + 2 TVD)
- •6. Impaired organ function (liver, kidney, heart, lungs) according to the
- •following definitions
- •o Shortening fraction <28%, or ejection fraction <55%, or clinical evidence of
- •congestive heart
- •failure or uncontrolled cardiac rythm disturbance
- •o Dyspnea at rest and/or pulse oxymetry <95% in air.
- •o ALT, Bilirubin >= 2 ULN
- •o Creatinine clearance and/or GFR <= 60 ml/min/1.73m2 and serum creatinine < 1.5
- •7. Any uncontrolled intercurrent 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
- •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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