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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neovii Biotech
• Treatments: Antibodies, Bispecific; Catumaxomab

Criteria

Inclusion Criteria:

• 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 60days following last catumaxomab infusion in the CASIMAS study

• Patients where standard therapy is either not available or no longer feasible

Exclusion Criteria:

• acute or chronic infection

• concomitant treatment with investigational products other than catumaxomab, cancer, chemo- or radiotherapy

• previous treatment with entirely murine monoclonal antibodies other than catumaxomab

• liver metastases with volume >70 % of liver metastasized tissue