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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01065246

Acronym

SECIMAS

Enrollment

Registered

2010-02-09

Start date

2009-11-30

Completion date

2011-10-31

Last updated

2012-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Ascites Due to Epithelial Carcinoma

Keywords

malignant ascites, second cycle, trifunctional

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).

Interventions

DRUGcatumaxomab

4 intraperitoneal infusions within 11 days administered over 3 hours via an indwelling catheter at the following doses: 10 - 20 - 50 - 150 µg catumaxomab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
proportion of patients who are able to receive a second cycle of catumaxomab	1 month

Secondary

Measure	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026