Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer - Full Text View

Sponsored by:	Fresenius Biotech GmbH
Information provided by:	Fresenius Biotech GmbH
ClinicalTrials.gov Identifier:	NCT00563836

Purpose

Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.

Condition	Intervention	Phase
Ovarian Cancer Epithelial Ovarian Cancer	Drug: Catumaxomab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Multicenter, Single-Arm, Phase II Study of the Trifunctional Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) Administered Intra- and Postoperatively in Patients With Epithelial Ovarian Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Immunoglobulins Catumaxomab Globulin, Immune

U.S. FDA Resources

Further study details as provided by Fresenius Biotech GmbH:

Primary Outcome Measures:

the rate of all specific postoperative complications newly observed during a period of 30 days after surgery [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

safety and efficacy endpoints [ Time Frame: EOS is on day 30, post study period additional 23 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	41
Study Start Date:	November 2007
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Catumaxomab 10 µg Catumaxomab intraoperatively and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16

Detailed Description:

An open label, multi-center, single-arm, phase II study according to Fleming´s one-stage design. The surgical procedure on Day 0 will be performed according to AGO State of the Art, followed by one intraoperative and four postoperative intraperitoneal administrations of catumaxomab within 16 days. The Discharge Visit will be performed when the patient is leaving the hospital but not earlier than 1 day after the last infustion, followed by the End of Study Visit on Day 30.

Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.

Eligibility

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

Criteria

Inclusion Criteria:

signed and dated informed consent form before any protocol-specific screening procedures
patients has a primary diagnosis of an epithelial ovarian cancer including clear cell carcinoma (FIGO IA(G2-G3) - IV)
Karnofsky index > or equal 70
female at an age of 18 years or older
negative pregnancy test

Exclusion Criteria:

exposure to prior cancer therapy specific for ovarian cancer
previos treatment with non-humanized mouse or rat monoclonal antibodies
known / suspected hypersensitivity to catumaxomab or similar antibodies
second malignangcy within the last 5 years
presence of constant immunosuppressive therapy
presence of symptomatic heart failure or occlusive arterial diseases
inadequate renal or hepatic function
presence of any acute or chronic systemic infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563836

Locations

Austria

Innsbruck, Austria
Germany
Klinikum Charité
Berlin, Germany, 13355

Sponsors and Collaborators

Fresenius Biotech GmbH

Investigators

Principal Investigator:

Jahlid Sehouli, MD

Klinikum Charité, 13355 Berlin

More Information

Publications:

Burges A, Wimberger P, Kümper C, Gorbounova V, Sommer H, Schmalfeldt B, Pfisterer J, Lichinitser M, Makhson A, Moiseyenko V, Lahr A, Schulze E, Jäger M, Ströhlein MA, Heiss MM, Gottwald T, Lindhofer H, Kimmig R. Effective relief of malignant ascites in patients with advanced ovarian cancer by a trifunctional anti-EpCAM x anti-CD3 antibody: a phase I/II study. Clin Cancer Res. 2007 Jul 1;13(13):3899-905.

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.

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.

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

Responsible Party:	Fresenius Biotech GmbH ( Fresenius Biotech GmbH )
Study ID Numbers:	IP-CAT-OC-02
Study First Received:	November 23, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00563836 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Fresenius Biotech GmbH:

ovarian cancer
catumaxomab
phase II

intraoperative
adjuvant
trifunctional antibody

Study placed in the following topic categories:

Ovarian Neoplasms
Immunologic Factors
Gonadal Disorders
Adjuvants, Immunologic
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases

Ovarian Epithelial Cancer
Genital Diseases, Female
Antibodies
Ovarian Cancer
Endocrinopathy
Endocrine Gland Neoplasms
Immunoglobulins

Additional relevant MeSH terms:

Ovarian Neoplasms
Immunologic Factors
Gonadal Disorders
Physiological Effects of Drugs
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases

Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Antibodies
Neoplasms by Site
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009