Conditions: Malignant Ascites
Keywords: Ascites Epithelial Cancer Epithelial Carcinoma Epithelial Ovarian Cancer Epithelial Ovarian Carcinoma Fallopian Tube Cancer Fallopian Tube Carcinoma Malignant Ascites Ovarian Cancer Ovarian Carcinoma Ovarian Epithelial Cancer Ovarian Epithelial Carcinoma Peritoneal Cancer Peritoneal Carcinoma Recurrent Ascites Recurrent Malignant Ascites Recurrent Symptomatic Malignant Ascites Symptomatic Malignant Ascites Symptomatic Ascites Neoplasms, Glandular and Epithelial Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 32
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for recurrent symptomatic malignant ascites.

Detailed description:
A multi-center, phase II study of catumaxomab in ovarian cancer patients with recurrent symptomatic malignant ascites requiring therapeutic paracentesis. Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 3-4 days. Each patient will participate in this study for up to 7 months (includes the baseline therapeutic paracentesis and screening period, 11 to 21 days treatment period, and up to 180 days/6 months follow-up), with monthly post-study follow-up for the lifetime of the patient.

Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells (DCs) and natural killer (NK) cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.

Arms:
arm 1: None

Interventions: intervention 1: catumaxomab
Intervention descriptions: intervention 1: Catumaxomab is administered intraperitoneally via an indwelling catheter (or port) as a 3-hour infusion 4 times (Days 0, 3, 7, and 10) in ascending doses (10 mcg, 20 mcg, 50 mcg, and 150 mcg, respectively).

Protocol document: