NL-OMON44066撤回2 期
RANDOMIZED PHASE 2 TRIAL COMPARING EXPERIMENTAL IMMUNOTHERAPY (ANTI-GD2 ANTIBODY, IL-2 S.C.,GM-CSF) IN RECURRENT HIGH RISK NEUROBLASTOMA PATIENTS WITH STANDARD IMMUNOTHERAPY (ANTI-GD2 ANTIBODY, IL-2 I.V., GM-CSF) IN PATIENTS WITH RECURRENT AND NEWLY DIAGNOSED HIGH RISK NEUROBLASTOMA - NB2013-HR PILOT GPOH/DCOG
Stichting Kinderoncologie Nederland0 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
- 撤回
- 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 17（—）
入选标准
- •Established diagnosis of neuroblastoma according to the international INSS criteria;High risk (HR): stage 4 over 18 months of age and MYCN amplified neuroblastoma of any stage and any age
- •- Recurrent or progressive neuroblastoma: completed re-induction chemotherapy (Germany and The Netherlands)
- •- Newly diagnosed neuroblastoma: Complete front-line treatment including induction chemotherapy, surgical removal and/ or local irradiation of the primary tumor and myeloablative chemotherapy with autologous stem cell reinfusion according to the actual guidelines of the GPOH/ DCOG (in The Netherlands only).;Achieved response status: stable disease or better (CR, VGPR, PR, SD) at the end of re-induction chemotherapy in recurrent disease and after ASCT in newly diagnosed disease;Written informed consent of parents or guardian and * if appropriate * of the patient.;For at least two weeks prior to start of trial medication
- •- off any standard or experimental treatment (and fully recovered from short-term major toxic effects)
- •- no tumour surgery (and fully recovered from any post-surgical complications)
- •- no immediate requirements for palliative chemotherapy, radiotherapy or surgery;The patient may have had prior CNS metastases provided the following criteria are all met:
- •- The patient*s CNS disease has been previously treated
- •- The patient*s CNS disease has been clinically stable for four weeks prior to starting this study (assessed clinically and by MRI or CT)
- •- The patient is off steroids for four weeks prior to starting the study and will not require them during the course of the study
- •- A patient with seizure disorders may be enrolled if well controlled on anticonvulsants and if no seizures have occurred within a 6 week period prior to starting trial treatment ;HIV sero-negative and neither active nor chronic-replicative hepatitis B infection ;adequate functions of the cor, lung, bone marrow, liver, kidney
排除标准
- •Significant intercurrent illnesses and/or any of the following:
- •- Symptoms of congestive heart failure or of uncontrolled cardiac arrhythmia
- •- Significant psychiatric disabilities or psychological conditions preventing treatment realization
- •- Uncontrolled seizure disorders
- •- Active infections
- •- Clinically significant neurologic deficit or objective peripheral neuropathy (> grade 2)
- •- Significant, symptomatic pleural effusions;Requirement or likely requirement for corticosteroids or other immunosuppressive drugs (except the medications recommended for conditions mentioned in the protocol);Platelet transfusion dependency;Concurrent treatment with any non-trial anticancer therapy or interventional study;Positive pregnancy test, lactation;Sexually active patients (male and female) at reproductive age not willing to use highly effective contraceptive methods according to the guidelines ICH M3 ;Neuroblastoma patients with actively progressing disease;Patients with HACA detected after previous antiGD2 immunotherapy;Known allergy or contraindications against one of the study drugs (IMP)
研究者
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