EUCTR2009-015936-14-DE进行中（未招募）1 期
PHASE II FEASIBILITY STUDY USING CH14.18/CHO ANTIBODY AND SUBCUTANEOUS INTERLEUKIN 2 AFTER HAPLOIDENTICAL STEM CELL TRANSPLANTATION IN CHILDREN WITH RELAPSED NEUROBLASTOMA - CH14.18-IL2
niversity Children´s Hospital Tübingen,0 个研究点目标入组 60 人开始时间: 2010年2月4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
- 60
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
- •Less than or equal to 21 years of age.
- •Histologically confirmed neuroblastoma.
- •Refractory to standard treatment (i.e. refractory disease) or relapse after previous autologous or allogenic stem cell transplantation.
- •Patient has undergone haploidentical stem cell transplantation prior to antibody infusion according to appendix IV at least 60 days prior to starting immunotherapy.
- •Serum glutamate pyruvate transaminase (SGPT) less than 2.5 times the upper limit of normal for age and total bilirubin less than 2 times the upper limit of normal for age. D-Dimers less than 2 times the upper limit of normal.
- •Creatinine clearance or radioisotope GFR greater than or equal to 40 ml/min/1.73m2.
- •Cardiac shortening fraction greater than or equal to 20% by echocardiogram.
- •Karnofsky/Lansky performance score (age appropriate) of greater than or equal to 50.
- •Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.
- •Written informed consent is obtained, and for minors a written agreement by parents or legal guardian.
- •All institutional and national requirements for human studies are met.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval > 450 milliseconds).
- •Patients with symptoms of congestive heart failure or uncontrolled cardiac rhythm disturbance.
- •Patients with significant psychiatric disabilities or uncontrolled seizure disorders.
- •Patients with active infections or active peptic ulcer, unless these conditions are corrected or controlled.
- •Patients with acute GvHD Grade III or IV or extensive chronic GvHD.
- •Patients with clinically significant, symptomatic, pleural effusions.
- •Patients who have had major surgery, (i.e. laparotomy or thoracotomy) within the past two weeks.
- •Patients who will more than 12 months post haploidentical stem cell transplantation at the time of starting the first cycle of immunotherapy.
- •Prior administration of ch14.18 antibody after allogeneic stem cell transplantation (prior administration after autologous transplantation will be acceptable)
- •HIV or Hepatitis B Surface (HBS) Ag positive. As presence of either may influence the ability if the immune system to be stimulated by this treatment.
研究者
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