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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neovii Biotech
ClinicalTrials.gov Identifier:
NCT01065246
First received: January 13, 2010
Last updated: October 2, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Malignant Ascites Due to Epithelial Carcinoma
Drug: catumaxomab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Neovii Biotech:

Primary Outcome Measures:
  • proportion of patients who are able to receive a second cycle of catumaxomab [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • puncture free survival [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]
  • incidence and severity of adverse events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Development of human-anti-mouse antibodies [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: November 2009
Study Completion Date: October 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065246

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

Publications:
Responsible Party: Neovii Biotech
ClinicalTrials.gov Identifier: NCT01065246     History of Changes
Other Study ID Numbers: IP-CAT-AC-04, 2009-014076-22
Study First Received: January 13, 2010
Last Updated: October 2, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Neovii Biotech:
malignant ascites
second cycle
trifunctional

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

ClinicalTrials.gov processed this record on October 21, 2014