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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Ascites Due to Epithelial Carcinoma

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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

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