Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer
Primary Purpose
Ovarian Cancer, Epithelial Ovarian Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Catumaxomab
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, catumaxomab, phase II, intraoperative, adjuvant, trifunctional antibody
Eligibility 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
Sites / Locations
- Klinikum Charité
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
the rate of all specific postoperative complications newly observed during a period of 30 days after surgery
Secondary Outcome Measures
safety and efficacy endpoints
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00563836
Brief Title
Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neovii Biotech
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Epithelial Ovarian Cancer
Keywords
ovarian cancer, catumaxomab, phase II, intraoperative, adjuvant, trifunctional antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Catumaxomab
Intervention Description
10 µg Catumaxomab intraoperatively and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16
Primary Outcome Measure Information:
Title
the rate of all specific postoperative complications newly observed during a period of 30 days after surgery
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
safety and efficacy endpoints
Time Frame
EOS is on day 30, post study period additional 23 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jahlid Sehouli, MD
Organizational Affiliation
Klinikum Charité, 13355 Berlin
Official's Role
Principal Investigator
Facility Information:
City
Innsbruck
Country
Austria
Facility Name
Klinikum Charité
City
Berlin
ZIP/Postal Code
13355
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17606723
Citation
Burges A, Wimberger P, Kumper C, Gorbounova V, Sommer H, Schmalfeldt B, Pfisterer J, Lichinitser M, Makhson A, Moiseyenko V, Lahr A, Schulze E, Jager M, Strohlein 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. doi: 10.1158/1078-0432.CCR-06-2769.
Results Reference
background
PubMed Identifier
15906359
Citation
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. doi: 10.1002/ijc.21165.
Results Reference
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PubMed Identifier
11410615
Citation
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. doi: 10.1177/002215540104900711.
Results Reference
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PubMed Identifier
10901380
Citation
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. doi: 10.1054/bjoc.2000.1237.
Results Reference
background
PubMed Identifier
10415020
Citation
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.
Results Reference
background
PubMed Identifier
11588051
Citation
Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526.
Results Reference
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Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer
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