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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01065246
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : October 3, 2012
Information provided by (Responsible Party):
Neovii Biotech

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.

Condition or disease Intervention/treatment Phase
Malignant Ascites Due to Epithelial Carcinoma Drug: catumaxomab Phase 2

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: catumaxomab Drug: catumaxomab
4 intraperitoneal infusions within 11 days administered over 3 hours via an indwelling catheter at the following doses: 10 - 20 - 50 - 150 µg catumaxomab
Other Name: Removab

Primary Outcome Measures :
  1. proportion of patients who are able to receive a second cycle of catumaxomab [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. puncture free survival [ Time Frame: 1-3 months ]
  2. incidence and severity of adverse events [ Time Frame: 1 month ]
  3. Quality of Life [ Time Frame: 1 month ]
  4. Development of human-anti-mouse antibodies [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01065246

Charité Campus Virchow Clinic
Berlin, Germany, 13353
Sponsors and Collaborators
Neovii Biotech
Principal Investigator: Jalid Sehouli, MD, Prof Charité Campus Virchow Clinic Berlin

Responsible Party: Neovii Biotech Identifier: NCT01065246     History of Changes
Other Study ID Numbers: IP-CAT-AC-04
2009-014076-22 ( EudraCT Number )
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: August 2012

Keywords provided by Neovii Biotech:
malignant ascites
second cycle

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathologic Processes
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs