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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Malignant Ascites Due to Epithelial Carcinoma

Intervention / Treatment
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* Drug: catumaxomab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: catumaxomab<br> | Drug: catumaxomab<br>* 4 intraperitoneal infusions within 11 days administered over 3 hours via an indwelling catheter at the following doses: 10 - 20 - 50 - 150 µg catumaxomab<br>* Other names: Removab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients who are able to receive a second cycle of catumaxomab |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| puncture free survival |  | 1-3 months | 
| incidence and severity of adverse events |  | 1 month | 
| Quality of Life |  | 1 month | 
| Development of human-anti-mouse antibodies |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malignant ascites, second cycle, trifunctional