Spots Global Cancer Trial Database for Safety Study of Second Intraperitoneal (I.P.) Infusion Cycle of Catumaxomab in Patients With Malignant Ascites

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Trial Identification

Brief Title: Safety Study of Second Intraperitoneal (I.P.) Infusion Cycle of Catumaxomab in Patients With Malignant Ascites

Official Title: 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

Study ID: NCT01065246

Conditions

Malignant Ascites Due to Epithelial Carcinoma

Interventions

catumaxomab

Study Description

Brief Summary: 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.

Detailed Description: 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).