Two-arm, randomized (2:1), open-label phase II/III study in EpCAM positive cancer patients with symptomatic malignant ascites using paracentesis plus the tri-functional antibody removab (anti-EpCAM x anti-CD3) versus paracentesis alone

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 216

Inclusion Criteria

1.Signed and dated informed consent,
2.Histological confirmed diagnosis of cancer,
3.Patients with symptomatic malignant ascites requiring therapeutic ascites puncture. The ascites volume estimated by the radiologist must exceed 1 liter.
4.EpCAM positive tumor cells in the ascites fluid,
5.Age: >/= 18 years,
6.Karnofsky Index >/=60
7.Negative pregnancy test at screening in women with childbearing potential,
8.Life expectancy >8 weeks,
9.At least 1 therapeutic ascites puncture within 5 weeks before screening puncture.
10.Patients who are refractory/resistant to chemotherapy or where the standard chemotherapy is no longer feasible
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Acute or chronic infections,
2.Exposure to investigational product, cancer chemo- or radiotherapy within the last 28 days (6 weeks for nitrosoureas or mitomycin C), before first infusion
3.Previous treatment with mouse or rat monoclonal antibodies,
4.Known or suspected hypersensitivity to removab or similar antibodies,
5.Inadequate renal function (Creatinine >1.5 x upper limit of normal [ULN]),
6.Inadequate hepatic function (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase >/= 5 x ULN; bilirubin >1.5 x ULN),
7.Platelets <80000 cells/qmm; absolute neutrophil count (ANC) <1500 cells/qmm,
8.Body mass index <17,
9.Patients with a reduced nutritional status requiring predominantly parenteral nutrition (>50% of energy intake),
10.Patients with gastric or small bowel feeding tube at study entry,
11.Patients with ileus within the last 30 days,
12.Patients with any other severe disease that would render a participation in the
study an undue risk,
13.Known brain metastases in cancer history,
14.Pregnant or nursing women or women with childbearing potential and males who are not using an effective contraceptive method during the study and at least 3 months after the last infusion,
15.History of myocardial infarction,
16.Signs or symptoms of relevant cardiovascular disease, congestive heart failure or cardiac arrhythmias (New York Heart Association [NYHA] class >II),
17.History of cerebrovascular accident,
18.Patients with portal vein obstruction or portal vein thrombosis diagnosed by CT-scan at screening,
19.Patients with extensive liver metastases (>70% of the liver is metastasized),
20.Inadequate respiratory function in the opinion of the investigator,
21.Any further condition which according to the investigator results in an undue risk of the patient by participating in the present study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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