This phase II single arm, open-label study investigate the safety of a second cycle of catumaxomab in patients with malignant ascites due to carcinoma, requiring their first therapeutic puncture after treatment in the CASIMAS study.
Up to 30 evaluable patients from the CASIMAS study will be enrolled. Catumaxomab will be infused intraperitoneally with 3hour constant-rate infusions 4 times within 11 days with ascending dosages (10 - 20 - 50 - 150 µg).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
4 intraperitoneal infusions within 11 days administered over 3 hours via an indwelling catheter at the following doses: 10 - 20 - 50 - 150 µg catumaxomab
Charité Campus Virchow Clinic
Berlin, Germany
proportion of patients who are able to receive a second cycle of catumaxomab
Time frame: 1 month
puncture free survival
Time frame: 1-3 months
incidence and severity of adverse events
Time frame: 1 month
Quality of Life
Time frame: 1 month
Development of human-anti-mouse antibodies
Time frame: 1 month
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