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

Primary Purpose

Malignant Ascites Due to Epithelial Carcinoma

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
catumaxomab
Sponsored by
Neovii Biotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Ascites Due to Epithelial Carcinoma focused on measuring malignant ascites, second cycle, trifunctional

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Campus Virchow Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

catumaxomab

Arm Description

Outcomes

Primary Outcome Measures

proportion of patients who are able to receive a second cycle of catumaxomab

Secondary Outcome Measures

puncture free survival
incidence and severity of adverse events
Quality of Life
Development of human-anti-mouse antibodies

Full Information

First Posted
January 13, 2010
Last Updated
October 2, 2012
Sponsor
Neovii Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT01065246
Brief Title
Safety Study of Second Intraperitoneal (I.P.) Infusion Cycle of Catumaxomab in Patients With Malignant Ascites
Acronym
SECIMAS
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 Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
October 2011 (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
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Ascites Due to Epithelial Carcinoma
Keywords
malignant ascites, second cycle, trifunctional

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
catumaxomab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
catumaxomab
Other Intervention Name(s)
Removab
Intervention Description
4 intraperitoneal infusions within 11 days administered over 3 hours via an indwelling catheter at the following doses: 10 - 20 - 50 - 150 µg catumaxomab
Primary Outcome Measure Information:
Title
proportion of patients who are able to receive a second cycle of catumaxomab
Time Frame
1 month
Secondary Outcome Measure Information:
Title
puncture free survival
Time Frame
1-3 months
Title
incidence and severity of adverse events
Time Frame
1 month
Title
Quality of Life
Time Frame
1 month
Title
Development of human-anti-mouse antibodies
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jalid Sehouli, MD, Prof
Organizational Affiliation
Charité Campus Virchow Clinic Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Campus Virchow Clinic
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

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

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