EUCTR2009-014076-22-SE进行中（未招募）不适用
Phase II open label study to evaluate the safety of a second i.p. infusion cycle of catumaxomab in patients with malignant ascites due to carcinoma, requiring their first therapeutic puncture after treatment in the CASIMAS study (IP-CAT-AC-03) - SECIMAS
Fresenius Biotech GmbH0 个研究点目标入组 30 人开始时间: 2010年5月31日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •Patients will be enrolled in this study only if they meet all of the following criteria:
- •Patients capable of understanding the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study has been obtained
- •Patients who have completed 4 infusions of catumaxomab in the CASIMAS study.
- •Age: = 18 years
- •Karnofsky index = 60%
- •Patients with malignant ascites requiring their first therapeutic ascites paracentesis after at least 60 days following last catumaxomab infusion in the CASIMAS study.
- •Patients where standard therapy is either not available or no longer feasible
- •Body mass index (BMI) between 17 and 40 kg/m2; prior to calculation of BMI reduce ‘body weight’ by weight of current estimated ascites volume (exploratory value is sufficient).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will not be enrolled in this study if they meet any of the following criteria:
- •Documented acute or chronic infection
- •Concomitant treatment with investigational products other than catumaxomab, cancer, chemo-, or radiotherapy
- •In cases of previous exposure to investigational product other than catumaxomab, cancer, chemo- or radiotherapy (except for local radiation therapy for bone marrow metastasis) patients must be excluded if not sufficiently recovered from previous treatment (toxicity present) based on adequate laboratory values and general status according to other in/exclusion criteria (i.e. exclusion if less than 1 or 2 weeks after a weekly or bi-weekly scheduled previous therapy regimen). Patients must not have been exposed to nitrosoureas or mitomycin C within 6 weeks prior to the first infusion of catumaxomab.
- •Previous treatment with entirely murine monoclonal antibodies other than catumaxomab
- •Known or suspected hypersensitivity to catumaxomab or similar antibodies
- •Inadequate respiratory function, including symptomatic pleural effusion, distant metastases other than peritoneal carcinomatosis that lead to significant and/or life threatening respiratory distress and dyspnea at rest due to complications of advanced malignancy or other disease, or patients requiring supportive oxygen therapy
- •Inadequate renal function (creatinine > 1.5 ? upper limit of normal [ULN] or GFR (Glomerular filtration rate) < 75% of LLN)
- •Inadequate hepatic function (aspartate aminotransferase [AST] > 5 x ULN; alanine aminotransferase [ALT] > 5 x ULN; bilirubin > 1.5 x ULN)
- •Platelets < 80,000 cells/mm3; absolute neutrophil count (ANC) < 1,500 cells/mm3
- •Albumin lower than 3 g/dL or total protein lower than 6 g/dL
- •Partial thromboplastin time (PTT) > 2 x ULN
- •Hemoglobin < 8 g/dL
- •Patients requiring entirely parenteral nutrition
- •Patients with ileus or with symptomatic subileus within the last 30 days
- •Signs or symptoms of relevant cardiovascular disease, congestive heart failure or cardiac arrhythmias (New York Heart Association [NYHA] class > II)
- •Liver metastases with volume > 70% of liver metastasized tissue
- •Known portal vein obstruction
- •Known brain metastases
- •Unable or unwilling to comply fully with the protocol
- •Patients with medical or psychological conditions, which the investigator believes would preclude compliance with the study requirements
- •Pregnant women, nursing mothers, lactating women, and men or women of child bearing potential who are unwilling to use reliable contraception (hormonal birth control methods including oral contraceptives and contraceptive implants or a barrier method of contraception such as male or female condom, diaphragm, cervical cap plus a spermicide). Effective contraception must be used for the duration of the study and for 6 weeks following completion of the study
- •Patients with any other severe disease that would render a participation in the study an undue risk according to judgment of investigator.
- •Patients put into an institution by the authorities of judicial court.
研究者
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