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

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 Fresenius Biotech GmbH:

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

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

Locations

Germany
Charité Campus Virchow Clinic
Berlin, Germany, 13353

Sponsors and Collaborators

Fresenius Biotech GmbH

Investigators

Principal Investigator:

Jalid Sehouli, MD, Prof

Charité Campus Virchow Clinic Berlin

More Information

Publications:

Heiss MM, Strohlein MA, Jager M, Kimmig R, Burges A, Schoberth A, Jauch KW, Schildberg FW, Lindhofer H. Immunotherapy of malignant ascites with trifunctional antibodies. Int J Cancer. 2005 Nov 10;117(3):435-43.

Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34.

Riesenberg R, Buchner A, Pohla H, Lindhofer H. Lysis of prostate carcinoma cells by trifunctional bispecific antibodies (alpha EpCAM x alpha CD3). J Histochem Cytochem. 2001 Jul;49(7):911-7.

Zeidler R, Mysliwietz J, Csanady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6.

Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.

Responsible Party:	Fresenius Biotech GmbH
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 Fresenius Biotech GmbH:

malignant ascites
second cycle
trifunctional

Additional relevant MeSH terms:

Ascites
Carcinoma
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

Neoplasms
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

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