EUCTR2014-000588-42-AT进行中（未招募）1 期
PHASE II STUDY OF MONOCLONAL ANTIBODY CH14.18/CHO CONTINUOUS INFUSION IN PATIENTS WITH PRIMARY REFRACTORY OR RELAPSED NEUROBLASTOMA
Medical University Greifswald0 个研究点目标入组 40 人开始时间: 2014年9月16日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •Both male and female patients will be considered eligible to enter the study if they satisfy all of the
- •following inclusion criteria:
- •a) = 12 months and = 21 years of age at the time of study entry
- •b) Diagnosis of neuroblastoma according to the INSS criteria
- •c) Tumour burden controlled by conventional therapy (except patients with early minimal bone marrow relapse) fulfilling one of the following criteria:
- •- Primary refractory patients with stage 4 disease
- •- Relapse after primary stage 4 disease
- •- Disseminated relapse after primary localized neuroblastoma.
- •d) Measurable and/or evaluable disease in any of the following sites (skeletal lesions, soft tissue lesions, lymph nodes and/or primary tumour site and/or bone marrow) as measured by mIBG scan, CT, MRI and/or immunocytology
- •e) Life expectancy of at least 12 weeks.
- •f) Performance status greater or equal to 70% (Lansky Score or Karnofsky)
- •g) Consent to the placement of a central venous line, if one has not already been placed
- •h) Off any standard or experimental treatment for at least two weeks
- •prior to start of immunotherapy (Day 1 of cycle 1) and fully recovered
- •from the short-term major toxic effects
- •i) No immediate requirements for palliative chemotherapy, radiotherapy or surgery
- •j) At least 2 weeks from any tumour surgery and fully recovered from any post-surgical complications
- •k) HIV sero-negative
- •l) Neither active nor chronic-replicative Hepatitis B infection
- •m) Females of childbearing potential must have a negative pregnancy test and must agree to use an effective birth control method during the whole study duration including the last FU visit.
- •Female patients who are lactating must agree to stop breast-feeding.
- •n) 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 (assessment must be made clinically and by CT or MRI).
- •- The patient is off steroids for four weeks prior to starting trial
- •treatment and will not require them during the course of the study.
- •o) Patients 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
- •p) All patients and/or their parents or legal guardians must sign a written informed consent.
- •q) Laboratory testing:
- •- Shortening fraction of = 30 % on Echocardiogram.
- •- FEV1 and FVC >60% of the predicted by pulmonary function tests. Children unable to do PFTs should have no dyspnoea at rest and a pulse oximetry >94% in room air.
- •- Adequate bone marrow function as defined by ANC >0.5 10^9/L, platelets 20 10^9/L and haemoglobin > 8.0 g/dL.
- •- Adequate liver function, as defined by an ALT or AST < 5 x normal and a total
- •bilirubin < 1.0 mg/dL.
- •- Adequate renal function, as defined by a serum creatinine <1.5 mg/dL or a creatinine clearance or radioisotope GFR of > 60 mL/minute/1.73 m2.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 39
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients are NOT eligible for this study if they meet any of the following exclusion criteria:
- •a) Progressive disease at the time of inclusion into the study.
- •b) ADA positivity due to previous treatment with an anti-GD2 antibody (e.g. ch14.18/SP2/0, ch14.18/CHO).
- •c) Previous treatment with ch14.18/CHO in this study
- •e) Requirement, or likely requirement, for corticosteroids or other immunosuppressive drugs.
- •f) Concurrent treatment with any non-trial anticancer therapies.
- •g) Patients with hypersensitivity against one component of the investigational product or against mouse proteins.
- •h) Female patients of childbearing potential if pregnant, nursing, or not using effective contraception during the treatment period, as the potential effects of ch14.18 on the fetus have not been determined.
研究者
相似试验
进行中（未招募）
1 期
PHASE II STUDY OF CH14.18/CHO IN PATIENTS WITH PRIMARY REFRACTORY OR RELAPSED NEUROBLASTOMAPRIMARY REFRACTORY OR RELAPSED NEUROBLASTOMAMedDRA version: 20.0Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-000588-42-DEMedical University Greifswald40
已完成
不适用
ot availablePER-043-10Thallion Pharmaceuticals, Inc,
进行中（未招募）
不适用
A PHASE I BRIDGING STUDY USING CH14.18/CHO ANTIBODY IN CHILDREN WITH REFRACTORY NEUROBLASTOMA (NB)EUCTR2005-001267-63-ITISTITUTO GIANNINA GASLINI12
进行中（未招募）
不适用
Clinical Study of Antibodies to Shiga Toxins 1 and 2Prevention of Shiga toxin-mediated complications resulting from Shiga toxin producing bacterial infections.MedDRA version: 14.1Level: LLTClassification code 10019515Term: Hemolytic uremic syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2011-006094-26-Outside-EU/EEAThallion Pharmaceuticals Inc42
进行中（未招募）
1 期
Estudio de fase II de uso de anticuerpo monoclonal anti-CD20 (ofatumumab) más ESHAP seguido de trasplante autólogo de progenitores hemopoyéticos para el tratamiento de linfoma de Hodgkin clásico en recaída, respuesta parcial o refractario a tratamiento de primera líneaEL PRESENTE ESTUDIO PROPONE TRATAR PACIENTES CON LINFOMA DE HODGKIN CLASICO REFRACTARIO, EN RESPUESTA PARCIAL O RECAIDA CON QUIMIOTERAPIA SEGUN DOSIS ESTANDAR DE ESHAP EN COMBINACION CON OFATUMUMAB CON LA FINALIDAD DE AUMENTAR LA TASA DE RESPUESTA GLOBAL Y DE REMISION COMPLETA PREVIO A UN TRASPLANTE AUTOLOGO DE PROGENITORES HEMOPOYETICOSMedDRA version: 12.1Level: LLTClassification code 10020328Term: Hodgkin's lymphomaEUCTR2009-016026-13-ESFUNDACION GELTAMO