Trial Information
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
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).
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
proportion of patients who are able to receive a second cycle of catumaxomab
Outcome Time Frame:
1 month
Safety Issue:
Yes
Principal Investigator
Jalid Sehouli, MD, Prof
Investigator Role:
Principal Investigator
Investigator Affiliation:
Charité Campus Virchow Clinic Berlin
Authority:
Germany: Paul-Ehrlich-Institut
Study ID:
IP-CAT-AC-04
NCT ID:
NCT01065246
Start Date:
November 2009
Completion Date:
October 2011
Related Keywords:
- Malignant Ascites Due to Epithelial Carcinoma
- malignant ascites
- second cycle
- trifunctional
- Ascites
- Carcinoma